The FDA's top regulator of cancer drugs played a key role in the rejection of a skin cancer therapy from Replimune Group, ...

The amount of frozen funds could be as high as $200 million, or potentially more than $300 million, according to two ...

Shares of Replimune (NASDAQ:REPL) plunged ~38% in the premarket on Monday after Stat News reported that the FDA’s top ...

Replimune stock falls as FDA denies skin cancer drug approval and investors sue over alleged misstatements tied to the IGNYTE ...

The FDA's top regulator of cancer drugs interceded in a review of a Replimune skin cancer therapy, contributing to its ...

The FDA has rejected Replimune’s request for approval of RP1, adding the melanoma drug candidate to the list of assets to receive complete response letters from the new-look agency. Investors sent the ...

Replimune said the agency had issued a complete response letter regarding the company’s biologics license application for RP1, its lead candidate to treat advanced melanoma in c ...

Following a complete response letter rejecting accelerated approval for RP1 in advanced melanoma, IGNYTE trial investigators are urging the FDA to reevaluate the therapy’s robust survival data, just ...

The rejection occurred amid broader turmoil at the FDA, which has been experiencing leadership changes, staff upheaval, and internal dysfunction. These organizational issues reportedly factored into ...

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

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

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 ...