Amgen submits new data to challenge FDA's proposal to withdraw Tavneos

Amgen submitted new evidence to the FDA on 23 July challenging the agency's proposed withdrawal of Tavneos, a rare-disease drug, citing over 70 real-world studies involving 2,200+ patients supporting its effectiveness and safety. The FDA proposed withdrawal in April citing lack of proven effectiveness and false statements in the original application, though the drug remains on the US market pending FDA commissioner action or Amgen's voluntary removal.

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