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TALZENNA Plus XTANDI Significantly Improves Radiographic Progression-Free Survival in Metastatic Prostate Cancer
Thursday, March 19, 2026 - 06:45amView pdfcopyCopy to clipboardOpen in tab
- Primary endpoint met in Phase 3 TALAPRO-3 study demonstrating a statistically significant and clinically meaningful reduction in risk of disease progression or death in HRR gene-mutated metastatic hormone sensitive prostate cancer
- Consistent rPFS efficacy benefit was observed in patients whose tumors harbored BRCA and non-BRCA HRR gene alterations
- Interim analysis showed a strong trend toward improvement in overall survival
- These results will be discussed with global health authorities to potentially expand TALZENNA indication in this earlier stage disease
NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced positive topline results from the Phase 3 TALAPRO-3 study of TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in people with homologous recombination repair (HRR) gene-mutated metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC).
The study met its primary endpoint, with TALZENNA plus XTANDI demonstrating a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS), compared to placebo plus XTANDI. The results markedly exceeded the pre-specified target hazard ratio of 0.63, with the majority of patients remaining progression-free at the time of analysis. Consistent efficacy benefit was also observed in patients whose tumors harbored BRCA and non-BRCA HRR gene alterations.
Vertex Announces Positive Week 36 Interim Analysis Results for Primary and All Secondary Endpoints in the RAINIER Phase 3 Trial of Povetacicept in Adults With IgA Nephropathy
- For the primary endpoint, patients treated with povetacicept achieved a 52.0% reduction from baseline in proteinuria as measured by 24-hour urine protein to creatinine ratio (UPCR) and achieved a statistically significant and clinically meaningful 49.8% reduction in UPCR versus placebo (P<0.0001) –
- For the first secondary endpoint, povetacicept treatment led to a 77.4% reduction from baseline in serum Gd-IgA1, resulting in a statistically significant and clinically meaningful reduction of 79.3% (P<0.0001) versus placebo; for the second secondary endpoint, 85.1% of povetacicept-treated patients achieved hematuria resolution, resulting in a statistically significant and clinically meaningful improvement of 61.7% (P<0.0001) versus placebo –
- Povetacicept was generally safe and well tolerated –
- Vertex to complete Biologics License Application by the end of March for potential U.S. Accelerated Approval –
BOSTON--(BUSINESS WIRE)--Mar. 9, 2026-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced positive data from a pre-specified Week 36 interim analysis of the ongoing Phase 3 RAINIER trial of povetacicept, an engineered fusion protein and dual inhibitor of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, in immunoglobulin A nephropathy (IgAN).
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260309179428/en/
The trial met its primary objective. In the interim analysis population, patients treated with povetacicept achieved a 52.0% reduction from baseline in urine protein to creatinine ratio (UPCR) at Week 36, with a statistically significant and clinically meaningful 49.8% UPCR reduction compared to placebo (P<0.0001). The reduction in proteinuria was consistent across all pre-specified subgroups.
Bristol Myers Squibb Announces Positive Phase 3 Results from the SUCCESSOR-2 Study of Oral Mezigdomide in Relapsed or Refractory Multiple Myeloma
Study marks the first positive Phase 3 study for mezigdomide and the second positive Phase 3 study for the Bristol Myers Squibb CELMoD program
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced positive interim Phase 3 results from the SUCCESSOR-2 study (NCT05552976). In the trial, oral mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus carfilzomib and dexamethasone alone (Kd) in patients with relapsed or refractory multiple myeloma (RRMM). Safety findings were consistent with the known profile of mezigdomide and the combination regimen. Patients will continue to be followed for survival and safety.
“We are excited by these results, which underscore Bristol Myers Squibb’s leadership in treating multiple myeloma and our unwavering commitment to patients living with this persistent and challenging disease,” said Cristian Massacesi, executive vice president, chief medical officer and head of development at Bristol Myers Squibb. “Importantly, these findings reinforce the value of our CELMoD program and our targeted protein degradation platform, and strengthen our confidence in bringing forward effective, accessible oral treatment options for patients with difficult-to-treat blood cancers and potentially beyond.”
March 02, 2026 AbbVie Announces Positive Topline Results from Phase 3 AFFIRM Study Evaluating SKYRIZI® (Risankizumab) Subcutaneous Induction in Patients with Crohn's Disease
- In the Phase 3 AFFIRM study in adults with moderately to severely active Crohn's disease, risankizumab (SKYRIZI®) achieved superiority for the co-primary and ranked secondary endpoints at week 12 for induction delivered by subcutaneous (SC) injection versus placebo1
- These data support strong efficacy of risankizumab in Crohn's disease while providing potential for an induction choice for patients1
- The safety profile of risankizumab SC induction was consistent with its known profile in Crohn's disease, with no new safety risks observed1
NORTH CHICAGO, Ill., March 2, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from the Phase 3, randomized, placebo-controlled, double-blind AFFIRM study evaluating the efficacy and safety of risankizumab (SKYRIZI®) subcutaneous (SC) induction treatment versus placebo in adult patients with moderately to severely active Crohn's disease (CD).1
The AFFIRM study results show significantly greater proportions of patients treated with risankizumab SC induction achieved the co-primary endpoints of Crohn's Disease Activity Index (CDAI) clinical remissiona (55% vs. 30%; p<0.0001) and endoscopic responseb (44% vs. 14%; p<0.0001) at week 12 compared to placebo.1 Among patients with clinical responsec after 12 weeks of risankizumab SC induction treatment followed by 12 weeks of maintenance, 67% achieved CDAI clinical remission at week 24 and 57% achieved endoscopic response at week 24.1\
SystImmune and Bristol Myers Squibb Highlight Positive Phase III Interim Topline Results for izalontamab brengitecan (Iza-bren) in Previously Treated Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer
Izalontamab brengitecan (Iza-bren) met its dual primary endpoints of progression free survival (“PFS”) and overall survival (“OS”) in an interim analysis of a Phase 3 trial (NCT06382142) conducted in China
BL-B01D1-307 is the third Phase III study in which iza-bren has achieved its primary endpoint(s)
REDMOND, Wash. & PRINCETON, N.J.--(BUSINESS WIRE)-- SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, and Bristol Myers Squibb (NYSE: BMY) today announced that SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin), reported positive topline results from a pre-specified interim analysis of a Phase III study (BL-B01D1-307) evaluating izalontamab brengitecan (iza-bren), an EGFR×HER3 bispecific antibody-drug conjugate (ADC), in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose disease progressed following prior taxane therapy.
In the pre-specified interim analysis, topline results showed that iza-bren demonstrated statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) compared to chemotherapy of physician’s choice, meeting both dual primary endpoints.
biotecHOPE™
U.S. FDA Grants Full Approval to Pfizer’s BRAFTOVI Combination Regimen in First-Line Metastatic Colorectal Cancer Tuesday, February 24, 2026 - 02:29pm
- The BRAFTOVI combination regimen is the only approved targeted regimen for first-line BRAF-V600E mutant metastatic colorectal cancer
- Pivotal results from the Phase 3 portion with mFOLFOX6 of the BREAKWATER trial demonstrated a clinically meaningful and statistically significant 51% risk reduction in death and a 47% risk reduction in disease progression or death compared to chemotherapy treatment with or without bevacizumab
- Expanded indication enables flexibility to use BRAFTOVI in combination with cetuximab and different fluorouracil-based chemotherapy regimens
NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation based on results from the global Phase 3 BREAKWATER trial (NCT04607421).
Merck Announces Positive New Data for ENFLONSIA™ (clesrovimab) for Infants and Children Under 2 Years of Age at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease Over Two RSV Seasons
February 19, 2026 5:15 am EST
Second season results from the Phase 3 SMART trial were presented at the 9th RSVVW Conference and will be shared with the U.S. FDA and other regulatory authorities
RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive second RSV season findings from the Phase 3 SMART trial (MK-1654-007) (NCT04938830) evaluating the safety, efficacy and pharmacokinetics of ENFLONSIA™ (clesrovimab) in infants and children at increased risk for severe respiratory syncytial virus (RSV) disease over two RSV seasons. The data were presented during an oral session (Abstract #P455) at RSVVW’26, the 9th conference of the Respiratory Syncytial Virus Foundation (ReSViNET) in Rome, Italy.
Bristol Myers Squibb Announces Positive Top-Line Results from Registrational Phase 2 Study of Luspatercept in Adults with Alpha (α)-Thalassemia
Both non-transfusion-dependent and transfusion dependent cohorts met their respective primary and secondary endpoints
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced positive top-line results from the ongoing, ex-US, Phase 2 registrational study (NCT05664737) evaluating Reblozyl® (luspatercept-aamt) versus placebo for anemia in adults with Alpha (α)-Thalassemia.
The non‑transfusion‑dependent (NTD) and transfusion‑dependent (TD) cohorts of the study met their respective primary endpoints, with Reblozyl demonstrating a statistically significant and clinically meaningful increase in hemoglobin levels in NTD patients with α‑thalassemia, and a statistically significant and clinically meaningful decrease in red blood cell (RBC) transfusion burden in TD patients with α‑thalassemia. The study also met all key secondary endpoints. Safety findings were consistent with the known profile of Reblozyl in thalassemia.
“These positive data further support the potential of Reblozyl for patients around the world,” said Cristian Massacesi, Executive Vice President, Chief Medical Officer and Head of Development, Bristol Myers Squibb. “This is the first and only registrational Phase 2 trial specifically designed to address the needs of patients, especially in China, with alpha-Thalassemia, a lifelong disease with limited treatment options and the potential for serious long‑term complications.”
The data will be presented at an upcoming medical congress and will be discussed with the Center for Drug Evaluation in China.
February 20, 2026 U.S. Food and Drug Administration (FDA) Approves Combination Treatment of VENCLEXTA® (venetoclax) and Acalabrutinib for Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL)
- First all-oral, fixed-duration combination regimen approved for previously untreated patients with CLL
- Approval supported by data from the Phase 3 AMPLIFY trial
- Regimen offers another option for the potential of time off treatment, marking a meaningful advance in long-term disease management
NORTH CHICAGO, Ill., Feb. 20, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the combination regimen of VENCLEXTA® (venetoclax) and acalabrutinib for the treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL). The approval is supported by data from the Phase 3 AMPLIFY trial.1
This milestone updates the treatment of CLL in the first-line setting, establishing the VENCLEXTA and acalabrutinib combination as the first and only all-oral, fixed-duration regimen for previously untreated patients. The regimen supports current standards of care by offering patients the potential for time off treatment and giving providers a new, targeted option that combines two classes of oral medications for CLL.
February 6, 2026 FDA Approves Label Update for Kite’s Yescarta® for Relapsed/Refractory Primary Central Nervous System Lymphoma
– Limitations of Use Removed for Rare and Aggressive Form of non-Hodgkin Lymphoma Based on Manageable Safety Profile with No New Safety Signals Identified –
SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) approved an update to the Yescarta® (axicabtagene ciloleucel) prescribing information removing the previous Limitations of Use in patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL). The updated label reinforces the robust safety data of Yescarta in eligible patients with R/R PCNSL; Yescarta is the only CAR T-cell therapy approved for R/R large B-cell lymphoma to have this Limitations of Use removed.
Primary central nervous system lymphoma is a rare and fast‑growing lymphoma that originates in the brain, spinal cord, eye, or cerebrospinal fluid. Prognosis for PCNSL remains poor, with a five‑year survival rate of approximately 30%. More than half of patients see their disease come back after the first treatment, with subsequent survival of approximately two months, highlighting the urgent need for new and better treatment options.
FDA Grants Priority Review for HYMPAVZI® (marstacimab) sBLA for the Treatment of Two Hemophilia A or B Patient Populations with Significant Medical Need Friday, February 06, 2026 - 06:45am
- Submission is to expand HYMPAVZI indication to the treatment of hemophilia A or B patients 6 years and older with inhibitors, and pediatric patients (ages 6 to 11) without inhibitors
- If approved, HYMPAVZI would become the first non-factor prophylactic treatment available for children aged 6 to 11 years with hemophilia B
NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE)today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company’s supplemental Biologics License Application (sBLA) for HYMPAVZI® (marstacimab) to expand the approved indication to include the treatment of hemophilia A or B patients 6 years and older with inhibitors, and pediatric patients (ages 6 to 11) with hemophilia A or B without inhibitors. In the U.S., HYMPAVZI is currently approved for the treatment of patients 12 years of age and older with hemophilia A without factor VIII (FVIII) inhibitors, or hemophilia B without factor IX (FIX) inhibitors.
February 03, 2026 AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) in Adults and Adolescents With Vitiligo
- Submissions are supported by data from the Phase 3 Viti-Up clinical studies demonstrating upadacitinib achieved the co-primary endpoints of at least a 50% improvement in total body re-pigmentation (T-VASI 50) and at least a 75% improvement in facial re-pigmentation (F-VASI 75) from baseline at week 48.1
- If approved, upadacitinib will be the first systemic medication available for patients with vitiligo, addressing important treatment needs for those living with the chronic, unpredictable autoimmune disease.
NORTH CHICAGO, Ill., Feb. 3, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for upadacitinib (RINVOQ®; 15 mg, once daily) for the treatment of adult and adolescent patients living with non-segmental vitiligo (NSV). The regulatory submissions to the FDA and EMA are supported by previously announced results from the Viti-Up studies evaluating the safety and efficacy of upadacitinib in patients with NSV.
January 21, 2026 New England Journal of Medicine Publishes Phase 3 ASCENT-04/KEYNOTE-D19 Results Supporting Trodelvy® Plus Keytruda® as a Potential New Standard of Care in First-line PD-L1+ Metastatic Triple-negative Breast Cancer
– Combination Reduced the Risk of Death or Disease Progression by 35% Versus Standard of Care in Frontline PD-L1+ Metastatic TNBC Setting –
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced The New England Journal of Medicine (NEJM) published the full results from the positive Phase 3 ASCENT-04/KEYNOTE-D19 study evaluating the combination of Trodelvy® (sacituzumab govitecan-hziy) plus Keytruda® (pembrolizumab) in first-line PD-L1+ (CPS ≥10) metastatic triple-negative breast cancer (TNBC). ASCENT-04 successfully met its primary endpoint of progression-free survival (PFS) with a 35% (HR: 0.65; p<0.001) reduced risk of disease progression or death for Trodelvy plus Keytruda (n=221) versus standard of care Keytruda plus chemotherapy (n=222). Median PFS with Trodelvy plus Keytruda was 11.2 months versus 7.8 months when Keytruda was given in combination with chemotherapy.
“Metastatic TNBC patients often show rapid progression and poor outcomes after current first-line therapies, illustrating the urgent need for new and more efficacious treatment options,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. “These results represent important progress toward our goal of delivering Trodelvy to patients in earlier lines of breast cancer treatment, with potential to become a backbone therapy for all frontline metastatic TNBC patients in need of innovative therapeutics.”
Lilly's sofetabart mipitecan receives U.S. FDA's Breakthrough Therapy designation for the treatment of certain patients with platinum-resistant ovarian cancer
January 20, 2026Download PDF
INDIANAPOLIS, Jan. 20, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sofetabart mipitecan (LY4170156) for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received prior bevacizumab and mirvetuximab soravtansine, if eligible. Sofetabart mipitecan is a novel folate receptor alpha (FRα) antibody-drug conjugate (ADC) that uses proprietary linker technology and an exatecan payload.
Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).
New clinical data highlights CAPLYTA® (lumateperone) as a promising option for achieving remission in adults with major depressive disorder
CAPLYTA® nearly doubled the likelihood of remission at six weeks compared to placebo as an adjunctive therapy to an antidepressant based on pooled data from two Phase 3 studies
65% of patients reached remission with CAPLYTA®, with 43% achieving sustained relief from symptoms, in a six-month open-label extension safety study
Newly approved as an adjunctive for major depressive disorder, CAPLYTA® supports the ultimate treatment goal of remission with robust short-term data and long-term open-label safety data
January 16, 2026
TITUSVILLE, NJ. (January 16, 2026) – Johnson & Johnson today announced a new analysis of Phase 3 data which found CAPLYTA® (lumateperone), in combination with an antidepressant, showed significantly greater remission rates in adults with major depressive disorder (MDD) than placebo plus an antidepressant at six weeks, with continued benefits observed through six months in an open-label extension study. The findings are featured in one of 11 abstracts from across Johnson & Johnson’s neuropsychiatry portfolio that were presented at the 64th Annual Meeting of the American College of Neuropsychopharmacology (ACNP), held from January 12-15, in Nassau, Bahamas.
23 January 2026 Issued: London, UK Trelegy Ellipta approved in China for use in adults with uncontrolled asthma
- Asthma indication introduces an important option for patients with uncontrolled symptoms
- Approval adds to existing indication in COPD, making Trelegy Ellipta the only single inhaler triple therapy available for both respiratory conditions in China
- Approximately 46 million adults in China have asthma1, with around half experiencing uncontrolled symptoms, putting them at increased risk of exacerbations2
GSK plc (LSE/NYSE: GSK) today announced that China’s National Medical Products Administration (NMPA) has approved a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of patients with asthma aged 18 years and older, adding to its current license for use in patients with chronic obstructive pulmonary disease (COPD). The approval means that FF/UMEC/VI is the first and only single inhaler triple therapy (SITT) approved for the maintenance treatment of both respiratory conditions in the country.
ZIIHERA Plus TEVIMBRA and Chemotherapy: A Potential New Standard for First-Line HER2+ Advanced GEA
Jan 06, 2026 1:30 PM
Combination therapy showed compelling survival and disease control compared to current standard, regardless of PD-L1 status
High GEA burden in Asia, where BeOne holds ZIIHERA rights, signals potential broad patient impact
Results to be presented as a Late-Breaking Abstract Oral Presentation at ASCO GI on January 8, 2026
SAN CARLOS, Calif.--(BUSINESS WIRE)-- BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced full results from the Phase 3 HERIZON-GEA-01 trial evaluating ZIIHERA® (zanidatamab), a HER2-targeted bispecific antibody, in combination with chemotherapy, with and without PD-1 inhibitor TEVIMBRA® (tislelizumab), as a first-line treatment for HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). These data, including the first interim overall survival (OS) analysis, will be presented as a Late-Breaking Abstract Oral Presentation (#LBA285) at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) on January 8, 2026, from 8:57- 9:07 a.m. PST.
BeiGene Ltd. Announced 11/14/2024 name change to BeOne Medicines and redomiciliation to Basel, Switzerland.
Changes stock ticker to ONC reinforcing global focus and commitment to oncology.
biotecHOPE™
Moderna & Merck Announce 5-Year Data for Intismeran Autogene in Combination With KEYTRUDA® (pembrolizumab) Demonstrated Sustained Improvement in the Primary Endpoint of Recurrence-Free Survival in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection
January 20, 2026 6:00 am EST
At a median five-year pre-planned follow-up of the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, intismeran autogene in combination with KEYTRUDA reduced the risk of recurrence or death by 49% (HR=0.510; [95% CI, 0.294–0.887]) compared to KEYTRUDA alone
The Companies plan to present further data from follow up analyses of the study’s primary and secondary endpoints at a future medical conference
Eight Phase 2 and Phase 3 clinical trials underway across multiple tumor types including melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma
CAMBRIDGE, Mass. and RAHWAY, N.J. / ACCESS Newswire / Jan. 20, 2026 / Moderna, Inc. (NASDAQ: MRNA) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced median five-year follow-up data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, evaluating intismeran autogene (mRNA-4157 or V940), an investigational mRNA-based individualized neoantigen therapy (INT), in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with high-risk melanoma (stage III/IV) following complete resection. In this pre-planned analysis, adjuvant treatment with intismeran autogene in combination with KEYTRUDA continued to demonstrate sustained and clinically meaningful improvement in the study’s primary endpoint, recurrence-free survival (RFS), reducing the risk of recurrence or death by 49% (HR=0.510; [95% CI, 0.294–0.887]; one-sided nominal p=0.0075) compared to KEYTRUDA alone. Moderna and Merck plan to present further data from follow up analyses of primary and secondary endpoints at an upcoming medical meeting.
January 16, 2026 AbbVie Announces Topline Results for Epcoritamab (DuoBody® CD3xCD20) from Phase 3 EPCORE® DLBCL-1 Trial in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
- Based on the topline results from the EPCORE® DLBCL-1 trial, AbbVie along with partner Genmab will engage global regulatory authorities to discuss next steps
NORTH CHICAGO, Ill., Jan. 16, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced topline results from the Phase 3 EPCORE® DLBCL-1 trial evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, compared to investigator's choice of chemoimmunotherapy in adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The study demonstrated an improvement in progression-free survival (PFS) (HR: 0.74 [95% CI 0.60 to 0.92])*. Improvements were observed in complete response rates (CRR), duration of response (DoR), and time to next treatment among patients treated with epcoritamab. The study did not demonstrate a statistically significant improvement in overall survival (OS) (HR: 0.96 [95% CI 0.77 to 1.20]).
EPCORE DLBCL-1 is the first Phase 3 study to demonstrate improvement in PFS in patients with R/R DLBCL who were treated with a CD3xCD20 T-cell engaging bispecific monotherapy. The global study enrolled 483 patients with R/R DLBCL with at least one prior line of therapy (73% had received two or more prior lines) who were ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT).
Bristol Myers Squibb Announces Positive Topline Results from Phase 3 SCOUT-HCM Trial Evaluating Camzyos (mavacamten) in Adolescents with Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
SCOUT-HCM demonstrated the superiority of Camzyos on the primary endpoint and multiple secondary endpoints
The overall safety results in this study were consistent with the established safety profile of Camzyos in adults
Positive results support the potential for Camzyos to be the first cardiac myosin inhibitor for the treatment of adolescent oHCM
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced positive topline results from SCOUT-HCM, a Phase 3 trial evaluating Camzyos (mavacamten) in the first study of a cardiac myosin inhibitor (CMI) in adolescents (ages 12 years to <18 years) with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The trial met its primary endpoint, demonstrating a statistically significant reduction from baseline in Valsalva left ventricular outflow tract (LVOT) gradient at Week 28 versus placebo, indicating Camzyos was effective in improving LVOT obstruction. Statistical significance was also met for multiple secondary endpoints, including those for clinically meaningful aspects of the disease. Safety results in the trial were consistent with the established safety profile of Camzyos in adults, and no new safety signals were reported in this new, younger population. The study continues with active treatment and long-term extension periods.
REGENXBIO Highlights Key 2026 Catalysts and Announces Positive Long-Term Functional Outcomes in Lead Duchenne Gene Therapy Program
Jan 11, 2026 at 3:00 PM EST
- New Phase I/II RGX-202 functional data demonstrates long-term, durable treatment effect at pivotal dose at 18 months
- Robust patient enrollment in confirmatory trial continues, expect majority of patients to be dosed by planned BLA filing, mid-year
- Expecting FDA PDUFA decision and multiple pivotal top-line data readouts in 2026 to support potential commercial launches 2026-2028
- In-house manufacturing and strategic global partnerships driving commercial readiness
- Presentation at 44th Annual J.P. Morgan Healthcare Conference Wednesday, January 14
ROCKVILLE, Md., Jan. 11, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) highlighted progress and upcoming anticipated milestones across its pipeline of AAV gene therapies for rare and retinal diseases.
"2026 is set to be a transformative year for REGENXBIO, as we enter commercial stage with two near-term catalysts from our three late-stage assets and a clear path to sustained growth," said Curran Simpson, President and CEO, REGENXBIO. "We are starting the year with exciting new long-term data for our Duchenne program, demonstrating how our comprehensive strategy to maximize the potential for therapeutic benefit across all our programs is resulting in positive outcomes for patients. We are continuing to set the bar high for how potentially life-changing gene therapies are discovered, developed, and manufactured; this year we are sharply focused on advancing our commercial readiness to enable successful launches of these medicines for patients in need.
Pfizer’s BRAFTOVI® Regimen with Additional Chemotherapy Backbone Increased Response Rates for Certain Patients with Metastatic Colorectal Cancer Saturday, January 10, 2026 - 10:00am
- Cohort 3 analysis from the BREAKWATER study shows objective response rate of 64% with BRAFTOVI plus cetuximab and FOLFIRI compared to 39% with standard-of-care treatment FOLFIRI with or without bevacizumab
- The BREAKWATER study demonstrates clinically meaningful and statistically significant results, which show potential flexibility in chemotherapy backbone for patients with BRAF V600E-mutant metastatic colorectal cancer
NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced positive results from Cohort 3, a separate randomized cohort of the pivotal BREAKWATER trial, evaluating BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and FOLFIRI (fluorouracil, leucovorin, and irinotecan) in patients with previously untreated metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. At the time of this analysis, the BRAFTOVI combination regimen with FOLFIRI and cetuximab demonstrated a clinically meaningful and statistically significant improvement in confirmed objective response rate (ORR) assessed by blinded independent central review (BICR) compared to patients receiving standard-of-care treatment FOLFIRI with or without bevacizumab (64.4% vs 39.2%, odds ratio =2.76, p=0.001). These data will be presented today in an oral presentation (Abstract 13) at the 2026 American Society of Clinical Oncology Gastrointestinal (ASCO GI®) Cancers Symposium and highlighted in the ASCO GI official press program.
FDA APPROVES UPLIZNA® FOR ADULTS WITH GENERALIZED MYASTHENIA GRAVIS UPLIZNA Offers gMG Patients Deep and Durable Symptom Control and Twice-Yearly Dosing* First and Only CD19-Targeted B Cell Therapy Approved in anti-AChR and anti-MuSK Ab+ gMG
THOUSAND OAKS, Calif., Dec. 11, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNA® (inebilizumab-cdon) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive. The approval offers patients a new targeted treatment option that has the potential for long-term disease control with just two doses a year, after two initial loading doses.
PADCEV® Plus Keytruda® Significantly Improves Survival for Patients with Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility Wednesday, December 17, 2025 - 06:45am
- PADCEV plus Keytruda is the first and only regimen without platinum-based chemotherapy to improve event-free and overall survival when used before and after surgery in cisplatin-eligible patients with muscle-invasive bladder cancer
- Positive EV-304 data, combined with the recent unprecedented results from the EV-303 trial, highlight the potential of this combination to become a new platinum-free standard of care in an earlier stage of bladder cancer
- Results from the Phase 3 EV-304 trial will be presented at an upcoming medical meeting and discussed with global health authorities for potential regulatory filings
TOKYO AND NEW YORK, December 17, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced positive topline results from an interim analysis of the Phase 3 EV-304 clinical trial (also known as KEYNOTE-B15) for PADCEV® (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with Keytruda® (pembrolizumab), a PD-1 inhibitor. This pivotal study is evaluating the combination as neoadjuvant and adjuvant treatment (before and after surgery) versus standard of care neoadjuvant chemotherapy (gemcitabine and cisplatin) in patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. The trial met its primary endpoint, demonstrating clinically meaningful and statistically significant improvements in event-free survival (EFS), and overall survival (OS), a key secondary endpoint.
December 11, 2025 U.S. Food and Drug Administration (FDA) Grants Priority Review to Bristol Myers Squibb's Application for Opdivo® (nivolumab) Plus Chemotherapy Combination for Classical Hodgkin Lymphoma The U.S. FDA assigned a target action date of April 8, 2026
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for adult and pediatric (12 years and older) patients with previously untreated Stage III or IV classical Hodgkin Lymphoma (cHL). The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 8, 2026.
“The FDA’s acceptance of our supplemental Biologics License Application for priority review marks a pivotal milestone as we aim to bring a new and much-needed first-line option to adolescents and adults newly diagnosed with advanced-stage classical Hodgkin lymphoma,” said Monica Shaw, Senior Vice President, Oncology Commercialization, Bristol Myers Squibb. “Opdivo in combination with AVD represents a potential new standard of care in the frontline treatment of advanced cHL for adolescents and adults. Hodgkin lymphoma remains a challenging disease, with an ongoing need for therapies that may deliver meaningful and durable outcomes early in a patient’s treatment journey. We look forward to collaborating with the FDA throughout the review process to bring this important option to patients as quickly as possible.”
The FDA filing acceptance is based on the Phase 3 SWOG S1826 (CA2098UT) study, evaluating Opdivo in combination with AVD for adult and pediatric (12 years and older) patients with previously untreated Stage III or IV cHL.
Lynozyfic™ (linvoseltamab) Monotherapy in Newly Diagnosed Multiple Myeloma (NDMM) Shows Impressive Responses, Supporting Rationale as a Potential Foundation in Frontline Treatment December 7, 2025 at 4:30 PM EST
All three dose groups (50 mg, 100 mg and 200 mg) showed impressive monotherapy efficacy, with VGPR+ (very good partial response or better) of ≥70% despite limited follow-up; evidence shows that these responses are expected to deepen over time
Across all dose groups, 95% (19 of 20 patients) of all evaluable VGPR+ patients achieved minimal residual disease negative status
Data featured in an ASH oral presentation; LINKER-MM4 is the first clinical trial to evaluate a BCMAxCD3 bispecific monotherapy in NDMM and is part of a broad clinical development program evaluating Lynozyfic-based regimens in earlier lines of treatment
Regeneron to host virtual ‘Regeneron Roundtable’ investor event to discuss its multiple myeloma development program on Wednesday, December 10 at 8:30 a.m. ET
TARRYTOWN, N.Y., Dec. 07, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced encouraging data from the Phase 1/2 LINKER-MM4 trial evaluating Lynozyfic™ (linvoseltamab) in adults with newly diagnosed multiple myeloma (NDMM) who were transplant eligible or ineligible were shared in an oral presentation at the American Society of Hematology (ASH) Annual Meeting. These data build on results from a broad clinical development program evaluating Lynozyfic in early lines of treatment, including precursor conditions, as monotherapy and in combination with standard-of-care or novel agents.
Legend Biotech Highlights New CARVYKTI® Data in Multiple Myeloma and First-in-Human Results from Novel CAR-T Platform in Non-Hodgkin Lymphoma at ASH 2025 Dec 6, 2025
- Triple-class exposed patients with three prior lines of therapy in CARTITUDE-1 and CARTITUDE-4 achieved a median PFS of 50.4 months after a single infusion of CARVYKTI®
- Translational analyses show stronger immune fitness and a more immunocompetent TME when CARVYKTI® is used earlier in the treatment journey
- Eighty percent of as-treated patients in CARTITUDE-4 with standard-risk cytogenetics remained progression-free and off treatment at 30 months after a single infusion of CARVYKTI®
- Promising first-in-human results from allogeneic CAR-T candidate LUCAR-G39D demonstrate encouraging safety and efficacy in B-cell non-Hodgkin lymphoma
SOMERSET, N.J., Dec. 06, 2025 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today announced new long-term clinical and translational data for CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) from the CARTITUDE-1 and CARTITUDE-4 studies in relapsed / refractory multiple myeloma (RRMM) patients. In triple-class-exposed patients who had received three prior lines of therapy, a median progression-free survival (mPFS) of 50.4 months was observed following a single infusion of CARVYKTI®. This represents one of the longest PFS outcomes reported for a BCMA-targeted CAR-T cell therapy in this heavily pretreated population.
These results, presented in an oral presentation (Abstract #92) at the 67th American Society of Hematology (ASH) Annual Meeting, add to a body of clinical evidence and real-world experience supporting the long-term benefits of CARVYKTI®, which has treated over 9,000 patients globally.
BioNTech and Bristol Myers Squibb Present First Global Phase 2 Data for PD-L1xVEGF-A Bispecific Antibody Pumitamig Showing Encouraging Efficacy in Advanced Triple-Negative Breast Cancer
BioNTech and Bristol Myers Squibb Present First Global Phase 2 Data for PD-L1xVEGF-A Bispecific Antibody Pumitamig Showing Encouraging Efficacy in Advanced Triple-Negative Breast Cancer
- Global interim Phase 2 data in locally advanced/metastatic triple-negative breast cancer (”TNBC”) show encouraging antitumor activity for investigational therapy pumitamig (BNT327/BMS986545) plus chemotherapy in first- and second-line patients
- Pumitamig plus chemotherapy achieved confirmed objective response rate (cORR) of 61.5%, unconfirmed ORR (uORR) of 71.8% and disease control rate (DCR) of 92.3% irrespective of PD-L1 expression levels
- Data highlight the potential of pumitamig for patients with TNBC, including PD-L1 low or negative (CPS<10) TNBC which has limited treatment options and high unmet need
- Data are consistent with the previously reported data from the 1L TNBC Phase 1b/2 trial conducted in China and confirm dose selection for the pivotal Phase 3 ROSETTA BREAST-01 trial
MAINZ, Germany, and PRINCETON, USA, December 9, 2025 BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Bristol Myers Squibb Company (NYSE: BMY, “BMS”) today announced the first interim data from a global randomized Phase 2 trial (NCT06449222) evaluating pumitamig (BNT327/BMS986545), an investigational bispecific antibody targeting PD-L1 and VEGF-A, plus chemotherapy in patients with locally advanced/metastatic triple-negative breast cancer (“TNBC”) irrespective of PD-L1 expression levels.
Lilly's Jaypirca (pirtobrutinib) significantly improved progression-free survival, reducing the risk of progression or death by 80%, versus chemoimmunotherapy in patients with treatment-naïve CLL/SLL December 9, 2025
The risk reduction observed in BRUIN CLL-313 is among the most compelling observed for a single agent BTK inhibitor in a front-line CLL study
These data will be simultaneously published in the Journal of Clinical Oncology and highlighted in a late-breaking oral presentation at the 2025 American Society of Hematology Annual Meeting and Exposition, and were featured as part of the meeting's press program
INDIANAPOLIS, Dec. 9, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced results from the Phase 3 BRUIN CLL-313 clinical trial of Jaypirca (pirtobrutinib), a non-covalent Bruton tyrosine kinase (BTK) inhibitor, versus bendamustine plus rituximab (BR), in treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions. Pirtobrutinib met its primary endpoint demonstrating a reduction in the risk of disease progression or death by 80% (HR=0.20 [95% CI, 0.11-0.37]; p<0.0001).
These data will be highlighted in a late-breaking oral presentation at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in Orlando, Florida and simultaneously published in the Journal of Clinical Oncology.
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HYMPAVZI® (marstacimab) Reduced Bleeds by 93% Compared to On-Demand Treatment in Adults and Adolescents with Hemophilia A or B with Inhibitors Saturday, December 06, 2025 - 05:15pm View pdfcopyCopy to clipboardOpen in tab Findings from the Phase 3 study were presented at the 67th American Society of Hematology Annual Meeting and Exposition and published in Blood NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE)today presented results from the Phase 3 BASIS study (NCT03938792) evaluating HYMPAVZI® (marstacimab) for adults and adolescents living with hemophilia A or B with inhibitors. The results demonstrated the superiority of HYMPAVZI in improving key bleeding outcomes compared to on-demand (OD) treatment with bypassing agents. HYMPAVZI was administered with a straightforward, once-weekly subcutaneous injection requiring minimal preparation and no treatment-related lab monitoring.
Incyte’s First-in-Class mutCALR-Targeted Monoclonal Antibody, INCA033989, Granted Breakthrough Therapy Designation by U.S. FDA December 7, 2025 at 9:30 AM EST PDF Version The Company plans to initiate a Phase 3 program evaluating INCA033989 in essential thrombocythemia (ET) patients with all types of CALR mutations in mid-2026, following alignment with regulators Updated safety and efficacy data for INCA033989 in ET, and new data in myelofibrosis (MF), will be presented at the upcoming 2025 ASH Annual Meeting WILMINGTON, Del.--(BUSINESS WIRE)--Dec. 7, 2025-- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to INCA033989, a first-in-class mutant calreticulin (mutCALR)-targeted monoclonal antibody, for the treatment of patients with essential thrombocythemia (ET) harboring a Type 1 CALR mutation who are resistant or intolerant to at least one cytoreductive therapy.
Johnson & Johnson receives European Commission approval of IMAAVY®▼ (nipocalimab), a new FcRn blocker offering sustained disease control in a broad population of people living with generalised myasthenia gravis (gMG) Nipocalimab is the first FcRn blocker approved in both adult and adolescent gMG patients aged 12 and older who are anti-AChR or anti-MuSK antibody-positive In the pivotal Phase 3 Vivacity-MG3 and Phase 2/3 Vibrance-MG studies over 24 weeks, nipocalimab demonstrated rapid and substantial reduction in immunoglobulin G levels, one of the root causes of gMG gMG patients taking nipocalimab demonstrated up to 20 months of sustained disease control and symptom relief in the Vivacity-MG3 study and ongoing open-label extension December 2, 2025 Share BEERSE, BELGIUM (01 December, 2025) – Johnson & Johnson today announced that the European Commission has approved a Marketing Authorisation for IMAAVY®▼(nipocalimab), a fully human FcRn-blocking monoclonal antibody, as an add-on to st
December 01, 2025 AbbVie to Present Phase 3 ECLIPSE Data Demonstrating Atogepant (AQUIPTA®) Superiority Over Placebo in Achieving Pain Freedom for the Acute Treatment of Migraine at the 19th European Headache Congress Open a printable version of this pageEmail the URL of this page to a friend Pivotal Phase 3 ECLIPSE study demonstrated atogepant is superior to placebo for achieving pain freedom at two hours after treatment of the first migraine attack (24.3% for atogepant vs. 13.1% for placebo)1 AbbVie has submitted an application to the European Medicines Agency for expanded use of atogepant for the acute treatment of adults with migraine across Europe NORTH CHICAGO, Ill., Dec. 1, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced primary results from the pivotal Phase 3 ECLIPSE study, evaluating the safety, efficacy and tolerability of atogepant (60 mg) versus placebo for the acute treatment of migraine in adults (with or without aura).
November 24, 2025 See all press releases Sign up for email alerts Bristol Myers Squibb Receives Approval from the European Commission to Expand Use of CAR T Cell Therapy Breyanzi for Relapsed or Refractory Mantle Cell Lymphoma In the TRANSCEND MCL trial, 82.7% of patients responded to Breyanzi, with 71.6% of patients achieving complete response Data corrected: Breyanzi demonstrated sustained clinical benefit, with 41.2%* of patients still in response at 24 months based on TRANSCEND MCL trial results PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has granted approval to Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.
November 18, 2025 AbbVie Announces U.S. FDA Approval of EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide for Relapsed or Refractory Follicular Lymphoma Open a printable version of this pageEmail the URL of this page to a friend - EPKINLY plus rituximab and lenalidomide (EPKINLY + R2) is now the first and only bispecific antibody combination therapy available for patients with relapsed or refractory follicular lymphoma after at least one line of systemic therapy - In the Phase 3 EPCORE® FL-1 trial, EPKINLY + R2 demonstrated significantly superior progression-free survival and overall response rates compared to standard of care R2 with approximately 3 out of 4 patients achieving a complete response - Approval marks third indication for EPKINLY and first-ever FDA approval for a bispecific combination therapy in lymphoma NORTH CHICAGO, Ill., Nov. 18, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that EPKINLY® (epcoritamab-bysp), a T-cell engaging
FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each with Padcev® (enfortumab vedotin-ejfv), as Perioperative Treatment for Adults with Cisplatin-Ineligible Muscle-Invasive Bladder Cancer Save November 21, 2025 4:12 pm EST Represents the first PD-1 inhibitor plus ADC regimens for this patient population RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Padcev® (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy. These approvals represent the first PD-1 inhibitor plus ADC regimens for this patient p
FDA GRANTS FULL APPROVAL TO AMGEN'S IMDELLTRA® IN EXTENSIVE STAGE SMALL CELL LUNG CANCER Global Confirmatory Phase 3 DeLLphi-304 Trial Showed IMDELLTRA Reduced Risk of Death by 40% Compared to Chemotherapy Underscores IMDELLTRA as a Recognized Standard of Care Treatment for Patients With Extensive Stage Small Cell Lung Cancer That Has Progressed THOUSAND OAKS, Calif., Nov. 19, 2025 /PRNewswire/ -- Amgen (NASDAQ: AMGN) announced today that the U.S. Food and Drug Administration (FDA) has granted full approval to IMDELLTRA® (tarlatamab-dlle) for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The decision to convert IMDELLTRA's prior accelerated approval to a full approval is based on data from the global Phase 3 DeLLphi-304 study. Additionally, the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) were recently updated to inclu
21 October 2025 Issued: London, UK For media and investors only GSK’s Shingrix new prefilled syringe presentation receives positive CHMP opinion Prefilled syringe offers a convenient ready-to-use administration option to healthcare professionals Marketing authorization in EU expected in December 2025 Shingles affects approximately 1.7 million people in Europe each year1 GSK plc (LSE/NYSE: GSK) today announced that the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to support the approval of Shingrix (GSK’s Recombinant Zoster Vaccine or RZV) in a prefilled syringe. Currently, the vaccine presentation consists of two vials, a lyophilised powder antigen and a liquid adjuvant, which are combined prior to administration. After approval by the European Commission, expected in December 2025, the new prefilled syringe will remove the need to reconstitute separate vials, simplifying the vaccine adm
Libtayo® (cemiplimab) Approved in the European Union as First and Only Immunotherapy for Adjuvant Treatment of Cutaneous Squamous Cell Carcinoma (CSCC) with High Risk of Recurrence after Surgery and Radiation November 19, 2025 at 7:00 AM EST PDF Version Approval based on results of landmark Phase 3 C-POST trial that show Libtayo is first immunotherapy to significantly improve disease-free survival in CSCC in the adjuvant setting, reducing the risk of recurrence or death by 68% (hazard ratio: 0.32; 95% confidence interval: 0.20-0.51; p<0.0001) Libtayo is the current standard of care in advanced CSCC in Europe, and this approval has the potential to change the treatment paradigm for patients in an earlier setting TARRYTOWN, N.Y., Nov. 19, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
EYLEA HD® (aflibercept) Injection 8 mg Approved by FDA for the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing Across Approved Indications November 19, 2025 at 4:10 PM EST PDF Version First and only FDA-approved treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period Monthly dosing option in all approved indications provides greater dosing flexibility for more personalized patient care TARRYTOWN, N.Y., Nov. 19, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
Merck Announces Positive Topline Results from the Pivotal Phase 3 Trial Evaluating Investigational, Once-Daily, Oral, Two-Drug, Single-Tablet Regimen of Doravirine/Islatravir (DOR/ISL) in Treatment-Naïve Adults with HIV-1 Infection Save November 19, 2025 6:45 am EST Investigational DOR/ISL is the first non-INSTI, two-drug regimen to demonstrate non-inferiority to BIC/FTC/TAF in a Phase 3 clinical trial in treatment-naïve adults with HIV-1 infection RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced topline results from the pivotal double-blind Phase 3 trial of the investigational, once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir [DOR/ISL (100 mg/0.25 mg)] in adults with HIV-1 infection who had not previously received antiretroviral treatment (treatment-naïve) (MK-8591A-053). The success criterion for the primary efficacy hypothesis, as measured by the percentage of participants with HIV-1
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Positive HERIZON-GEA-01 Phase 3 Results Support Ziihera® (zanidatamab-hrii) as HER2-Targeted Agent-of-Choice and Ziihera Combination Regimens as New Standard of Care in First-Line HER2-Positive Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma November 17, 2025 Download PDF Ziihera plus chemotherapy showed a clinically meaningful and statistically significant improvement in PFS versus trastuzumab and chemotherapy, and a clinically meaningful effect with a strong trend toward statistical significance for OS at the first OS interim analysis Ziihera plus the PD-1 inhibitor Tevimbra® (tislelizumab) and chemotherapy demonstrated clinically meaningful and statistically significant improvements in OS and PFS versus trastuzumab and chemotherapy Company plans to submit a supplemental BLA for this indication in first half of 2026 For U.S. media and investors only DUBLIN, Nov. 17, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ)
European Commission Approves Subcutaneous Administration of KEYTRUDA® (pembrolizumab) for All Adult Indications Approved in the European Union Save November 19, 2025 6:30 am EST This marks the approval of the first and only subcutaneous immune checkpoint inhibitor in Europe that can be administered by a health care provider in as little as one minute RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved a new subcutaneous (SC), or under the skin, route of administration and a new pharmaceutical form (solution for injection) of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy. KEYTRUDA SC™, as it will be marketed in the European Union (EU), [known as KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], is a subcutaneous injection containing pembrolizumab and berahyaluronidase alfa and has been approved for use across all 33 KEYTRUDA indications
Thursday, Oct 16, 2025 Genentech Expands Xofluza® Access And Affordability For Upcoming Flu Season With Direct-To-Patient Launch Genentech’s new program will provide access to Xofluza through select pharmacies with a $50 cash pay option, 70 percent lower than the list price Direct-to-patient program focuses on same day delivery in select U.S. markets and improves affordability for patients who are underinsured, uninsured or self-pay This program addresses the significant public health impact that flu continues to have on society; the overall flu burden during the 2024-25 season was the most severe in seven years South San Francisco, CA -- October 16, 2025 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)
Flunomics: Assessing the True Impact of Flu Published on: November 4, 2025 The severe 2024/2025 flu season needs to be a wake-up call. Lives were lost, and fragilities in public health systems were laid bare. Yet assessing the true impact of flu remains a challenge, as national, regional and international surveillance systems often leave important gaps in the picture.
November 7, 2025 Gilead’s Livdelzi® Demonstrates Sustained Efficacy in Primary Biliary Cholangitis (PBC), Offering Alkaline Phosphatase (ALP) Reduction, Itch Relief and Potential to Slow Disease Progression Share Article copy-icon copy-icon copy-icon copy-icon Back – New Data Exclusive to Livdelzi Highlights its Potential as an Effective and Well-Tolerated Option for PBC Patients Switching from Obeticholic Acid – – Analysis of Phase 3 ASSURE Study Finds Livdelzi Shows Promising Data on Liver Stiffness in PBC Patients After 3 Years – – Livdelzi Data in PBC Participants Provide Outcomes for Long-Term Biochemical Response, which Slows Disease Progression and Sustained Reductions in Chronic Itch, which Impacts Patient Wellbeing and Quality of Life – FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced new long-term data reinforcing the safety and efficacy profile of Livdelzi® (seladelpar) for people living with primary biliary cholangitis (PBC).
Nov 8, 2025 Vertex Presents Updated Phase 1/2 Data From RUBY-3 Study That Continue to Demonstrate Best-in-Class Potential for Povetacicept in Adults with IgA Nephropathy and Primary Membranous Nephropathy at American Society of Nephrology Kidney Week - 48-week data show a 64% decrease from baseline in proteinuria in IgA nephropathy, 82% decrease from baseline in proteinuria in primary membranous nephropathy, and stabilization of estimated glomerular filtration rate across both diseases - - Vertex on track to initiate rolling submission of Biologics License Application for potential accelerated approval to the U.S. Food and Drug Administration this year; full enrollment completed for Phase 3 RAINIER trial in IgA nephropathy - - Povetacicept in primary membranous nephropathy granted Fast Track Designation by the U.S. Food and Drug Administration and Phase 2/3 pivotal trial initiated - BOSTON--(BUSINESS WIRE)--Nov. 8, 2025-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
November 3, 2025 Gilead and Kite Showcase Continued Progress in Transforming Blood Cancer Care With New Cell Therapy Data at ASH 2025 Share Article copy-icon copy-icon copy-icon copy-icon Back – Updated Results from Phase 2 Pivotal iMMagine-1 Study of Anito-cel for Relapsed/Refractory Multiple Myeloma to be Presented Orally – – New Findings Reinforce Yescarta’s® Curative Potential as Second-Line Therapy in Patients with Relapsed/Refractory Large B-Cell Lymphoma – – Next-Generation CAR T-cell Therapies Suggest High Response Rates and Encouraging Durability in B-Cell Malignancies – FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company,
October 29, 2025 AbbVie Announces Positive Topline Results from Phase 3 Pivotal Studies Evaluating Upadacitinib (RINVOQ®) in Adults and Adolescents with Vitiligo upadacitinib (RINVOQ®) achieved the co-primary endpoints of 50% reduction in Total Vitiligo Area Scoring Index (T-VASI 50) from baseline and 75% reduction in Facial Vitiligo Area Scoring Index (F-VASI 75) from baseline at week 481 Both studies met key ranked secondary endpoints1 NORTH CHICAGO, Ill., Oct. 29, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from two replicate Phase 3 studies evaluating the safety and efficacy of upadacitinib (RINVOQ®;15 mg, once daily in adult and adolescent patients living with non-segmental vitiligo (NSV).1 NSV, the most common form of vitiligo (occurring in over 90% of patients), is characterized by symmetrical and bilateral white patches on both sid
XTANDI® Plus Leuprolide Reduced Risk of Death by 40% vs Leuprolide Alone in Men with a Type of Advanced Prostate Cancer Sunday, October 19, 2025 - 04:15am View pdfcopyCopy to clipboardOpen in tab The probability of survival at 8 years was an unprecedented 78.9% with XTANDI plus leuprolide versus 69.5% with leuprolide, in men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence1 XTANDI is the first and only androgen receptor inhibitor-based regimen to demonstrate overall survival benefit in this patient population, supporting its earlier use in this setting Final results from the Phase 3 EMBARK study are being presented in a late-breaking oral session at ESMO 2025 and simultaneouslypublished in The New England Journal of Medicine NEW YORK & NORTHBROOK, Ill.--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and Astellas Pharma U.S. Inc.
Enhertu reduced the risk of disease recurrence or death by 53% vs. T-DM1 in patients with high-risk HER2-positive early breast cancer following neoadjuvant therapy in DESTINY-Breast05 Phase III trial PUBLISHED 18 October 2025 More than 92% of patients treated with AstraZeneca and Daiichi Sankyo’s Enhertu were free of invasive disease at three years DESTINY-Breast05 presented in ESMO Presidential Symposium alongside DESTINY-Breast11 reinforce potential for Enhertu to become a foundational treatment in curative-intent early breast cancer setting
US Food and Drug Administration accepts for review AstraZeneca’s Supplemental Biologics License Application for self-administration of FluMist Quadrivalent PUBLISHED 24 October 2023 Potential to be the first and only self-administered flu vaccine AstraZeneca’s Supplemental Biologics License Application (sBLA) for the approval of a self- or caregiver-administered option for FluMist Quadrivalent, a needle-free nasal spray, has been accepted for review by the US Food and Drug Administration (FDA). If approved, FluMist will be the first flu vaccine available to be self-administered by eligible patients or administered by caregivers, adding an additional option to be vaccinated against influenza. The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer or administer FluMist to eligible patients 2-49 years of age when given instructions for use without any additional guidance. FluMist, which is sprayed into the nose,
Krystal Biotech Announces FDA Approval of Updated VYJUVEK® Label September 15, 2025 Download PDF Revised label allows treatment of DEB patients from birth VYJUVEK can now be applied by patients and caregivers PITTSBURGH, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that the United States Food and Drug Administration (FDA) approved a label update for VYJUVEK® (beremagene geperpavec-svdt) that expands the VYJUVEK eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth and provides patients full flexibility with respect to VYJUVEK application and managing wound dressings.
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October 23, 2025 Gilead to Showcase Interim Long-Term Efficacy Data for Livdelzi® (Seladelpar) in Primary Biliary Cholangitis (PBC) and Investigational Bulevirtide in Chronic Hepatitis Delta
Lilly's Verzenio® (abemaciclib) prolonged survival in HR+, HER2-, high-risk early breast cancer with two years of treatment October 17, 2025 Verzenio is the first contemporary therapy in over two decades to demonstrate a significant overall survival benefit in adjuvant HR+, HER2−, high-risk early breast cancer Seven-year results from the Phase 3 monarchE trial also show Verzenio plus endocrine therapy demonstrated sustained benefits in invasive disease-free survival and distant relapse-free survival These data were simultaneously published in Annals of Oncology and presented as a late-breaking oral session at the European Society for Medical Oncology (ESMO) Annual Meeting INDIANAPOLIS, Oct. 17, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)
October 19, 2025 Trodelvy® Reduces Risk of Disease Progression or Death by 38% Versus Chemotherapy as First-Line Therapy in Patients With Metastatic Triple-Negative Breast Cancer in ASCENT-03 Study
TUKYSA Combination Significantly Improves Progression-Free Survival as First-Line Maintenance in HER2+ Metastatic Breast Cancer in HER2CLIMB-05 Trial Tuesday, October 14, 2025 - 06:45am View pdfcopyCopy to clipboardOpen in tab NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE
BioNTech and DualityBio Announce Phase 3 Trial of ADC Candidate BNT323/DB-1303 Met Primary Endpoint of Progression Free Survival in HER2-Positive Metastatic or Unresectable Breast Cancer 5 September 2025 PDF Version Trastuzumab pamirtecan (BNT323/DB-1303), an investigational next-generation antibody drug-conjugate (“ADC”) targeting HER-2, met its primary endpoint of progression free survival (“PFS”) in interim analysis of a Phase 3 trial (NCT06265428) conducted in China Positive result in the NCT06265428 trial marks milestone in BioNTech and DualityBio’s strategic collaboration initiated in April 2023 Additional global Phase 3 DYNASTY-Breast02 trial (NCT06018337) evaluating trastuzumab pamirtecan in patients with metastatic HER2-low breast cancer is ongoing and on track MAINZ, Germany and SHANGHAI, China, September 05, 2025 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Duality Biologics (Suzhou) Co., Ltd. (“DualityBio”)
FDA APPROVES TEZSPIRE® FOR CHRONIC RHINOSINUSITIS WITH NASAL POLYPS Approval Broadens Indication for TEZSPIRE to a Second Disease Characterized by Epithelial-Driven Inflammation THOUSAND OAKS, Calif., Oct. 17, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) approved TEZSPIRE® (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older.
Merck and Eisai Announce WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) Met Primary Endpoint of Progression-Free Survival (PFS) in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma Save October 28, 2025 6:30 am EDT First treatment regimen to demonstrate a statistically significant improvement in PFS for patients whose disease progressed following anti-PD-1/L1 therapy compared with cabozantinib in a Phase 3 study LITESPARK-011 marks the first positive Phase 3 study of a HIF-2 alpha inhibitor in combination with a multi-targeted VEGF tyrosine kinase inhibitor RAHWAY, N.J. & NUTLEY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today announced that the Phase 3 LITESPARK-011 trial evaluating the dual oral regimen of WELIREG® (belzutifan), Merck’s first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, plus LENVIMA® (lenvatinib), an orally available multiple receptor tyrosine kinase inhib
European Commission Approves KEYTRUDA® (pembrolizumab) as Part of a Treatment Regimen for Adults with Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC) Expressing PD-L1 (CPS ≥1) Save October 29, 2025 6:45 am EDT KEYTRUDA monotherapy now approved as neoadjuvant treatment, continued as adjuvant treatment combined with radiotherapy with or without concomitant cisplatin then as monotherapy Based on results of KEYNOTE-689, this represents the first and only approval in the European Union for an anti-PD-1 treatment option for adults with resectable LA-HNSCC whose tumors express PD-L1 (CPS >1) RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, as monotherapy for the treatment of resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) as neoadjuvant treatment, continued as ad
Merck Announces KEYTRUDA® (pembrolizumab) Plus WELIREG® (belzutifan) Met Primary Endpoint of Disease-Free Survival (DFS) in Certain Patients With Clear Cell Renal Cell Carcinoma (RCC) Following Nephrectomy Save October 28, 2025 6:45 am EDT First combination regimen to demonstrate improvement in DFS compared to KEYTRUDA monotherapy for these patients in the adjuvant setting LITESPARK-022 is the second positive Phase 3 study for WELIREG as part of a combination regimen in RCC RAHWAY, N.J.,--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the Phase 3 LITESPARK-022 trial in patients with clear cell renal cell carcinoma (RCC) following nephrectomy. In this study, KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with WELIREG® (belzutifan), Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, given in the adjuvant setting, demonstrated a statistically si
U.S. FDA Approves Updated Indication for WINREVAIR™ (sotatercept-csrk) in Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1 Pulmonary Hypertension) Based on Phase 3 ZENITH Study Save October 27, 2025 6:45 am EDT Adding WINREVAIR to background PAH therapy improved exercise capacity and WHO functional class (FC), and reduced the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death ZENITH data add to growing body of evidence supporting a positive benefit risk profile of WINREVAIR in a broad range of adult patients with PAH RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the U.S. product label based on the Phase 3 ZENITH trial for WINREVAIR™ (sotatercept-csrk) for injection, 45mg, 60mg. WINREVAIR, an activin signaling inhibitor, is now FDA-approved for the treatment of adults with pul
May 31, 2025 Trodelvy® Plus Keytruda® Reduces Risk of Disease Progression or Death by 35% Versus Keytruda and Chemotherapy in First-Line PD-L1+ Metastatic Triple-Negative Breast Cancer Share Article copy-icon copy-icon copy-icon copy-icon Back – First Pivotal Phase 3 Trial to Show Superiority of a TROP-2 Antibody-Drug Conjugate, Trodelvy, Plus Keytruda Versus Standard of Care in 1L Metastatic TNBC – – Early Trend in Improvement in Overall Survival Observed – FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced Trodelvy® (sacituzumab govitecan-hziy) plus Keytruda® (pembrolizumab) reduced the risk of disease progression or death by 35% (HR: 0.65) versus standard of care Keytruda plus chemotherapy in first-line treatment for patients with PD-L1+ (CPS ≥10) metastatic triple-negative breast cancer (TNBC). Trodelvy when given in combination with Keytruda resulted in a median progression-free survival (PFS) of 11.2 months vs 7.8 months when Keytruda