FDA Proposes Withdrawing Amgen Autoimmune Drug Tavneos
The FDA proposed withdrawing Amgen's Tavneos citing a lack of effectiveness and false statements. The agency also noted reports of drug-induced liver injury.
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洞察:
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The United States Food and Drug Administration (FDA) proposed withdrawing approval for AMGEN INC’s vasculitis drug Tavneos on Monday. The agency cited 76 cases of liver injury and eight deaths linked to the drug since its 2021 approval. Investors face potential revenue loss from a treatment once expected to anchor Amgen’s rare disease portfolio.
