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

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

(Alliance News) - AstraZeneca PLC on Monday said the US Food & Drug Administration has granted priority review for its immunotherapy drug Imfinzi for some cancer forms.

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

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

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

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 ...

--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 ...