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Amgen's Tavneos Faces Proposed U.S. Withdrawal Over Liver Injury Deaths on May 22; Unapproved in China

GateNews

According to Amgen's statement on May 22, the U.S. FDA has proposed withdrawing approval for Tavneos (avelumab), a rare disease treatment, following reports of liver injury-related deaths. The drug was previously approved in China as well.

Amgen China confirmed that Tavneos received approval from the National Medical Products Administration (NMPA) in November 2024 but has not been commercialized in China. As of May 22, no patients in China have received treatment with the drug.

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