The FDA escalated its action against Amgen’s Tavneos (immunosuppressant for a rare disease), alleging that trial data supporting the drug’s approval were manipulated. The agency moved to withdraw the approval and remove the product from the market, following new information that it said includes “untrue statements of material fact.” Amgen previously refused to withdraw Tavneos voluntarily, arguing the medicine is safe. With the FDA’s additional steps, the case underscores heightened scrutiny of the integrity of pivotal-study datasets, especially for rare-disease approvals where evidence thresholds are tightly contested. Regulatory and market implications are immediate for providers and patients relying on Tavneos while substitutes and ongoing trials are evaluated for efficacy and safety. The FDA’s allegations also set a more aggressive enforcement tone for companies facing similar compliance questions across portfolios.