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

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

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

Replimune Group, Inc. (NASDAQ:REPL) saw its stock nosedive 77% on Tuesday after the company revealed it received a Complete ...

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.

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

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

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 ...

--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 ...