FDA Commissioner Defends Replimune Melanoma Drug Rejection Amid Criticism
FDA Commissioner Marty Makary has defended the agency's decision to reject Replimune's melanoma therapy RP1, citing adherence to scientific recommendations. The rejection was based on Replimune's use of a single-arm trial, which the FDA deemed insufficient. This decision has sparked controversy and criticism, with some accusing the FDA of being overly restrictive. Makary emphasized that all decisions are based on the recommendations of primary review teams and denied any influence from external pressures. The FDA's transparency policy, which includes publishing rejection letters, aims to increase accountability in the biopharma industry. 
