
Amgen keeps Tavneos on market as regulators review trial data and safety
Amgen says it will not voluntarily withdraw Tavneos after an FDA request and will continue talks with regulators, even as the EMA re-examines Tavneos data integrity. The FDA is reviewing the original ChemoCentryx trial data and the drug’s risk-benefit profile due to rare hepatotoxicity, while Amgen asserts the underlying data are sound. Tavneos, approved in 2021 in the US and 2022 in the EU, remains a small but growing part of Amgen’s portfolio as it pursues milestones for other drugs like Uplizna and guides 2026 revenue higher after a 2025 showing of about $36.7B.




