US FDA moves to withdraw Amgen's rare disease drug approval; shares gain

Amgen

28/04/2026 13:42

** Shares of Amgen AMGN.O rise 1.1% to $343.98 premarket

** The U.S. FDA, late on Monday, proposed withdrawing approval of Amgen's rare disease drug Tavneos after concluding it has not been proven effective

** The agency said new information showed the original approval application contained false or withheld data

** The FDA also flagged serious safety concerns, including liver injury cases and reported deaths linked to the drug

** Amgen disagreed with the FDA, saying Tavneos remains safe and effective and that it will respond to the agency

** Tavneos will remain on the market unless Amgen withdraws it or the FDA commissioner orders its removal, FDA said.

** As of last close, stock up ~4% YTD

 (Reporting by Kamal Choudhury in Bengaluru)

 ((Kamal.Choudhury@thomsonreuters.com;))