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

The FDA on Tuesday rejected a skin therapy from Replimune Group, suggesting a hardened stance on drug approvals under new ...

The FDA has rejected Replimune’s request for approval of RP1, adding the melanoma drug candidate to the list of assets to ...

Replimune (NASDAQ:REPL) announced on Tuesday that the U.S. Food and Drug Administration (FDA) issued a Complete Response ...

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

The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (CT03767348) trial in advanced melanoma was not ...

Replimune Group, Inc. faces FDA setbacks with RP1, raising financial risks and dilution concerns. Click here to find out why ...

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 – a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies – ...

Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...

Replimune, which was seeking approval of RP1 in combination with Bristol Myers Squibb's Opdivo for the treatment of advanced melanoma, on Tuesday said the FDA issued a so-called complete response ...

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 ...