The FDA proposed withdrawing Amgen’s Tavneos (avacopan) after alleging “untrue statements” in the drug’s approval application. The agency’s Center for Drug Evaluation and Research put forward action to withdraw the NDA for the C5aR antagonist that was at the core of Amgen’s 2022 buyout of Chemocentryx. The move escalates a long-running dispute over data integrity and could remove the product from the US market if it progresses. Amgen has said previously it would not voluntarily withdraw the therapy. The case underscores that FDA scrutiny can reach beyond clinical endpoints and into the administrative record used to support approvals and post-marketing status.