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

Rosen Law Firm, a global investor rights law firm, announces it has filed a class action lawsuit on behalf of purchasers of the securities of Replimune Group, Inc. (NASDAQ: REPL) between November 22, ...

A 55-year-old man’s swollen toes and fingers turned out to have a much stranger explanation than expected. In a recent case ...

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

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