
03/07/2025
$MRK wins FDA Priority Review for its supplement label update on WINREVAIR, backed by the Phase 3 ZENITH trial showing a 76% drop in morbidity/mortality risk: https://ibn.fm/hCqrX
US pharma giant Merck & Co today revealed that the US Food and Drug Administration (FDA) has accepted and granted priority review for a supplemental Biologics License Application (sBLA) to update the US product label for Winrevair (sotatercept-csrk) based on the Phase III ZENITH trial.