The FDA issued new safety alerts tied to liver injury and deaths associated with Amgen’s Tavneos (avacopan), according to reports summarizing agency correspondence. The updates cite cases of severe drug-induced liver injury and describe a “reasonable evidence” causal association with the drug. This renewed scrutiny comes after earlier FDA action that prompted a push for withdrawal tied to processes used to re-adjudicate trial endpoints, with Amgen declining to pull the product voluntarily. The new notice increases clinical and commercial pressure around monitoring and risk communication. Regulators’ focus on mortality-linked injury profiles raises immediate implications for prescribing, pharmacovigilance workflow, and ongoing discussions between sponsors and the agency. For the broader biotech market, the Tavneos safety action shows that even approved immune-modulating therapies can face fast-moving post-market regulatory review when signals emerge or interpretations shift.