European regulators moved to withdraw Tavneos in a formal escalation of the drug’s data-integrity controversy. The EMA’s CHMP recommended revoking marketing authorization after it said it could not rely on the original assessment package, citing “incorrect and misleading” data and data integrity concerns. The decision follows a parallel FDA trajectory: the FDA had already proposed withdrawal in the US and is expected to take the matter to a hearing. Together, the EMA/ FDA actions signal a tightening stance on evidentiary reliability for rare-disease approvals built on contested datasets. For Amgen and partners, the immediate implication is a near-term disruption to commercial availability in Europe and a continued uncertainty timeline in the US, alongside potential scrutiny of study conduct and documentation used for regulatory review.