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

The lawsuit comes after Replimune investors witnessed a 77% collapse in the price of their shares on July 22 when the company announced that the Food and Drug Administration (FDA) had rejected its ...

The FDA has issued a CRL to Replimmune regarding the BLA for vusolimogene oderparepvec (RP1) in combination with nivolumab for advanced melanoma.

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 ...

A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...

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

The FDA’s decision to reject Replimune’s (NASDAQ:REPL) lead asset RP1 for a type of skin cancer known as melanoma appears to ...

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

Replimune (REPL) stock in focus as the FDA rejects its lead drug RP1 as part of a combination regimen for melanoma, a type of ...

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.