Revision History

Replimune's cancer drug RP1 was rejected twice by the FDA, but after the resignation of Commissioner Marty Makary and the departure of key officials who opposed approval, the agency invited the company to resubmit — raising questions about whether political upheaval, rather than new clinical evidence, opened the door. The case has become a flashpoint in a broader debate about executive branch influence over drug regulation and whether FDA independence can survive an era of intensifying political pressure.