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- Amgen defends Tavneos as FDA, European regulators and Japanese doctors raise safety concernsAmgen said it continues to support its rare-disease therapy Tavneos despite recent safety alerts. The U.S. FDA has indicated it wants the drug removed from the market after a report of 20 deaths l…
- FDA leadership overhaul follows firing of acting CDER director; 20 deaths linked to Amgen’s Tavneos in JapanThe FDA announced another leadership change, removing acting directors of its two main drug review centers. Tracy Beth Høeg, acting head of the Center for Drug Evaluation and Research (CDER), poste…