The New England Journal of Medicine retracted the 2021 pivotal Phase 3 report for Amgen’s Tavneos (avacopan) after FDA investigations found primary endpoint assessments for nine patients were re-adjudicated after database lock and after unblinding. The retraction adds new pressure to the ongoing regulatory dispute over trial conduct and disclosures. Tavneos received FDA approval in 2021 for ANCA-associated vasculitis, but the retraction follows escalating scrutiny by the agency, including earlier concerns raised by FDA staff and subsequent action proposals tied to risk-benefit reassessment. Amgen has resisted withdrawal efforts and said it is preparing for a hearing with its own third-party reviewer. The case now becomes a high-profile test for how regulators weigh peer-reviewed evidence when endpoints are changed post-lock, and how sponsors document protocol and adjudication processes across submissions.