Biotech News

Replimune Announces FDA Accelerated Approval of TUDRIQEVTM in Combination with Nivolumab for Unresectable Advanced Cutaneous Melanoma After Progression on an anti-PD-1 Based Regimen

Replimune Group (REPL)Replimune GroupFDA / regulatory

Broad label to address high unmet need in advanced melanoma Replimune will host conference call on August 6, 2026 at 4:30 p.m. ET. WOBURN, Mass., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a commercial stage biotechnology company pioneering the development of novel

Related news

REPLReplimune Group2026-07-30 22:15 EST

Replimune Announces Favorable Outcome of FDA's Cellular, Tissue, and Gene Therapies Advisory Committee Meeting for RP1 in Advanced Melanoma

BMYBMYBristol-Myers Squibb Company2026-08-13 21:12 EST

U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb's First CELMoD Therapy ZENBEXUS™, in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone (ZDd) for Patients with Multiple Myeloma, as Early as First Relapse

IDYAIDEAYA Biosciences2026-08-31 10:00 EST

IDEAYA Biosciences Announces Successful FDA Type C Meeting for IDE849, DLL3 TOP1 ADC, on Phase 3 Registrational Trial Design for Potential Accelerated and Full Approval in Extensive Stage Small Cell Lung Cancer

COGTCogent Biosciences2026-09-15 12:00 EST

Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) for Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)

RVMDRevolution Medicines2026-09-14 20:05 EST

Revolution Medicines Announces U.S. FDA Breakthrough Therapy Designation for RASONQUE™ (daraxonrasib) in Combination with Chemotherapy for First Line Metastatic Pancreatic Cancer

BNTXBioNTech2026-08-27 20:30 EST

Pfizer and BioNTech Receive U.S. FDA Approval for XFG-adapted COVID-19 Vaccine

GSKGSK plc2026-08-24 07:01 EST

Jemperli (dostarlimab) accepted for priority review by the US FDA for dMMR/MSI-H locally advanced rectal cancer

RVMDRevolution Medicines2026-07-22 20:05 EST

Revolution Medicines’ New Drug Application for Daraxonrasib Accepted for Review by U.S. FDA for Previously Treated Metastatic Pancreatic Cancer

ERASErasca2026-08-24 12:00 EST

Erasca Granted FDA Fast Track Designation for Pan-RAS Molecular Glue ERAS-0015 in Patients with Metastatic Pancreatic Adenocarcinoma

REPLReplimune Group2026-09-03 12:00 EST

Replimune to Present at the Cantor Global Healthcare Conference 2026

Replimune Group

Oncolytic Immunotherapy Platform Replimune develops engineered herpes-simplex-virus-based immunotherapies that selectively replicate within tumors, directly destroy cancer cells, release tumor antigens, and stimulate systemic antitumor immunity. Its viruses are armed with immune-activating components intended to enhance local tumor...

Recent company news

Stock data

Close
13.07 USD
Market cap
732.42M USD
Exchange
NASDAQ
Sector
Biopharma
Location
United States