The U.S. FDA identified eight deaths associated with Amgen’s autoimmune treatment Tavneos and flagged more than 70 cases of severe liver injury. Amgen said it previously notified the agency about the risk, as regulators continue to assess the scope and severity of harms tied to the therapy. The announcement raises the likelihood of intensified labeling scrutiny, post-marketing controls, or additional regulatory communications for clinicians treating autoimmune indications with Tavneos. It also underscores how fast-moving safety updates can alter risk-benefit discussions during ongoing real-world use. Amgen’s response—and any follow-on FDA actions—will be closely watched by the immunology community given the potential for downstream treatment interruption and monitoring changes.