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

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 ...

The US Food and Drug Administration (FDA) has extended the review period for the Biologics License Application (BLA) for ...

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

GSK (GSK) stock in focus as the company secures EU approval for Blenrep combo therapies targeting the blood cancer multiple ...

Investing.com -- Atara Biotherapeutics Inc (NASDAQ: ATRA) stock surged 7% after the U.S. Food and Drug Administration (FDA) accepted the filing of its Biologics License Application (BLA) for ...

London: GSK plc has announced the extension of the US Food and Drug Administration (FDA) review period for the Biologics ...

The FDA has decided not to approve vusolimogene oderparepvec (RP1) in combination with nivolumab for advanced melanoma.

The FDA has accepted the resubmitted BLA for tabelecleucel (tab-cel), intended for the treatment of Epstein-Barr virus ...

US biotech Avidity Biosciences’ stock rose 4% on Wednesday after the company announced that the US Food and Drug ...

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