The FDA identified eight deaths tied to Amgen’s Tavneos (avacopan) and flagged more than 70 cases of severe liver injury associated with the autoimmune therapy. The agency’s update heightens safety attention on drug-induced liver injury monitoring and risk management expectations. Amgen said it previously notified the agency about the risk. The FDA’s communication may affect label language, pharmacovigilance intensity, and future prescribing patterns for patients with vasculitis treated with Tavneos. For biotech and pharma teams, the key operational question is how quickly hepatotoxicity mitigation plans are updated across sites and post-marketing obligations—particularly for therapies with relatively recent approval histories.