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

Replimune said the agency had issued a complete response letter regarding the company’s biologics license application for RP1 ...

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 ...

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

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

Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration has accepted the company’ s supplemental Biologics License Application for Columvi ® in ...

Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing next-generation CAR T-cell therapies for patients ...

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

Capricor plans to commence the filing of a BLA in October of 2024 seeking full approval of deramiocel for the treatment of DMD-cardiomyopathy with full submission expected by year-end 2024. The ...

These updates support Ocugen in its efforts to pursue its goal of 3 biologics license applications (BLA) in the next 3 years.

The submission of this supplemental biologics license application is based on findings from the phase 3 CEPHEUS study, according to the release. Researchers conducting the trial evaluated the safety ...