Posted by Michael Wonder on 03 Jul 2025
FDA grants priority review for Winrevair (sotatercept-csrk) to update label based on results from ZENITH trial
2 July 2025 - Merck today announced that the US FDA has accepted and granted priority review for a new supplemental biologics license application seeking approval to update the US product label based on the Phase 3 ZENITH trial for Winrevair (sotatercept-csrk)
The FDA has set a PDUFA, or target action date, of 25 October 2025.
