The U.S. Food and Drug Administration requested Amgen withdraw Tavneos from the market following ongoing safety and efficacy questions, while Amgen publicly said it will not comply with the request. The dispute follows years of scrutiny over the drug’s benefit‑risk profile in rare‑disease indications. Amgen’s statement that it will not pull the drug sets up a regulatory standoff with possible legal and clinical ramifications, as stakeholders weigh patient access against agency determinations. The case underscores tensions that can arise when long‑standing therapies face renewed regulatory reassessment. Why it matters: A forced withdrawal or protracted negotiation would affect patients with rare vasculitides, set precedent for regulatory interactions over marketed biologics, and could influence how companies plan post‑market safety programs.