European regulators moved to pull Amgen’s Tavneos from the market after an assessment found the data submitted for the application “incorrect and misleading.” The EMA recommendation follows a broader integrity review and aligns with an FDA position that also supported withdrawal in April. A separate FDA process update landed for Replimune’s twice-rejected melanoma immunotherapy RP1. The agency has set an early August decision date for a resubmission seeking accelerated approval, with an advisory committee expected in late July. Together, the actions underscore how regulators are tightening scrutiny on evidence packages and trial conduct even as sponsors try to re-enter the market through re-filing and resubmissions.