FDA's bid to pull vasculitis drug Tavneos runs into resistance

The US FDA wants to withdraw Tavneos, a drug for a rare autoimmune vasculitis approved in October 2021, saying pivotal trial data was manipulated and citing reports of serious liver injury. The European Union has already pulled it and the UK plans to. The trial paper was retracted by NEJM. The drug, now owned by Amgen, costs $220,000 a year and earned nearly half a billion dollars in 2025.