Replimune (REPL) won over the FDA to submit a marketing application for its lead asset RP1 for the third time despite previous rejections, thanks to the intervention of White House officials, The Wall ...

Shares of Replimune Group REPL soared 85.7% on Friday after the company announced that it had aligned with the FDA on the resubmission of the biologics license application (BLA) for its lead pipeline ...

US FDA reverses course on Regenxbio's rare-disease gene therapy, backs accelerated approval bid Regenxbio said on Monday the U.S. FDA has indicated that existing data for its rare-disease gene therapy ...

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