Shares fell 75% to $3.04, putting the stock on track for a record closing low, according to Dow Jones Market Data. The stock ...

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

The CRL was given because the FDA did not consider the phase 1/2 IGNYTE trial to be an adequate and well-controlled clinical ...

Among reasons for the rejection, the agency cited a lack of US patient representation in the STARGLO trial assessing ...

In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...

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 ...

Tabelecleucel, an allogeneic, EBV-specific T-cell immunotherapy, works by targeting and eliminating EBV-infected cells.

-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 ...