Atara Biotherapeutics Inc (NASDAQ:ATRA) saw its stock jump 7% following the U.S. Food and Drug Administration’s acceptance of ...

These updates support Ocugen in its efforts to pursue its goal of 3 biologics license applications (BLA) in the next 3 years.

Nanoscope Therapeutics submitted the first modules of a biologics license application for MCO-010, an investigational gene ...

Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration ...

The FDA has issued a complete response letter to Replimune indicating it is unable to approve the biologics license ...

NEW YORK, July 23, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflamm ...

Merck (MRK) announced the FDA has accepted the Biologics License Application, or BLA, for clesrovimab, the company’s investigational prophylactic long-acting monoclonal antibody designed to ...

AbbVie Submits Biologics License Application to U.S. FDA for TrenibotulinumtoxinE (TrenibotE) for the Treatment of Glabellar Lines. PR Newswire. NORTH CHICAGO, Ill., April 24, 2025 ...

-BLA to be Supported by Existing and Natural History Cardiac Data as Discussed with the FDA- -Initial Label Would Include All Patients with Cardiomyopathy Associated with Duchenne Muscular ...

--Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has issued a Complete Response Letter for the Biologics License Application for linvoseltamab in ...

The FDA has accepted BioMarin Pharmaceutical’s biologics license application for Vimizim, an enzyme therapy that could be used to treat Mucopolysaccharidosis Type IVA or Morquio A Syndrome, according ...

Takeda Pharmaceutical Company has submitted a biologics license application to the FDA for its Crohn’s disease and ulcerative colitis treatment vedolizumab, according to a Gastroenterology & Endoscopy ...