FDA turns up heat on Amgen, proposing to rescind approval of Tavneos
28th April 2026 Uncategorised 0The FDA has told Amgen that it is proposing to withdraw the approval of the rare disease drug Tavneos. The FDA cited new information that indicates that data was “manipulated” to facilitate the approval of Tavneos. In addition, the FDA is “increasingly concerned about the safety of Tavneos,” pointing to cases of serious drug-induced liver injury.
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Source: fierce