The FDA flagged serious safety concerns tied to Amgen’s Tavneos (tavneos, avacopan) in its latest regulatory disclosure, identifying more than 70 cases of severe liver injury and eight deaths associated with the autoimmune treatment. The agency’s actions highlight ongoing post-market vigilance for hepatotoxicity risk. At the same time, a separate regulatory track is drawing attention to how FDA handles therapies that previously received complete response letters (CRLs). Biocentury reports that Biohaven, Regenxbio, and Sydnexis held unusual meetings with FDA’s chief counsel following high-profile setbacks, signaling a potential pathway for re-engagement after regulatory refusal. Together, the two developments point to a market where safety signals and prior review outcomes can quickly reshape timelines and engagement strategies with regulators.