UK pharma major AstraZeneca this morning revealed that its supplemental Biologics License Application (sBLA) for Imfinzi ...

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 ...

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 ...

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 ...

--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 ...

-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 ...

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 ...

Lupus nephritis is a type of kidney disease where the immune system attacks the kidneys. The company said that the FDA is expected to make a decision on approval by October 2025.. The application ...

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 ...

The announcement comes as the company seeks to file a Biologics License Application (BLA) for Re... advertisement. Seeking Alpha. Mesoblast, FDA agree on marketing application for cell therapy. 15h.

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 ...