Europe's CHMP reverses endorsement of Tavneos as Amgen FDA hearing looms

As Amgen prepares to defend Tavneos’ market approval in the U.S., the company has received a bad omen overseas, with regulators recommending that the ANCA-associated vasculitis drug lose its authorization in the European Union after a new review led to the conclusion that its benefits are “no longer proven to outweigh its risks.”