The FDA flagged more than 70 cases of severe liver injury and eight deaths associated with Amgen’s autoimmune treatment Tavneos, prompting renewed scrutiny of the drug’s risk profile. In its safety update, the agency identified the fatalities within the context of severe hepatic adverse events. Amgen said it had previously notified the FDA about the risk, indicating an ongoing regulator-company dialogue around risk communications and monitoring. The Tavneos signal is particularly consequential for clinicians treating autoimmune indications, given the need for practical liver monitoring and patient selection. The FDA’s identification adds pressure on Amgen to reinforce labeling and post-marketing surveillance as the regulator evaluates next steps.