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 ...

Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration ...

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

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.

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

The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.

The FDA has issued a complete response letter to Replimune indicating it is unable to approve the biologics license ...

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 ...

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