Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug ...

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

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, ...

Prefilled syringe eliminates the need to reconstitute separate vials prior to administration and simplifies the vaccine process.

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

GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...

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 ...

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

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

LEO Pharma, a global leader in medical dermatology, announced today that the U.S. Food and Drug Administration (FDA) ha ...