The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has joined the US Food and Drug Administration in challenging the approval basis for Amgen’s and Vifor’s inflammatory drug Tavneos, according to separate regulatory tracks. CHMP recommendation follows an FDA move to withdraw marketing authorization in the US, with both agencies citing data integrity concerns. In Europe, the CHMP recommendation to revoke signals a significant escalation beyond routine post-marketing review. A parallel US process is set for an FDA hearing over a proposed withdrawal. For biotech and pharma, the Tavneos case underscores how regulatory scrutiny can pivot from benefit-risk assessments to fundamental questions about the underlying evidence package—and how quickly market access can unravel once data integrity becomes the central issue.