The US Food and Drug Administration (FDA) has been criticized for its handling of a contentious review of a skin cancer therapy from Replimune Group, which led to the treatment’s last-minute rejection. Leadership changes, staff upheaval, and internal dysfunction within the agency have contributed to the decision, leaving Replimune “caught in the middle.” Three FDA officials with direct knowledge of the matter shared their insights anonymously, shedding light on the complex factors that influenced the rejection.
Source: https://www.statnews.com/2025/08/04/replimune-skin-cancer-drug-rejection-pazdur-prasad