Merck (MRK) announced that the U.S. FDA has accepted and granted priority review for a new supplemental Biologics License Application seeking approval to update the U.S. product label based on the Phase 3 ZENITH trial for WINREVAIR. In 2024, WINREVAIR was approved for the treatment of adults with pulmonary arterial hypertension to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events. The FDA has set a Prescription Drug User Fee Act, or target action date, of Oct. 25, 2025.
Don’t Miss TipRanks’ Half-Year Sale
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
- Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on MRK:
- Merck reports ACIP recommends Enflonsia in infants younger than 8 months
- Expected breakthrough year against H.I.V. fades as U.S. pulls support, NYT says
- Merck says Phase 3 HYPERION study of WINREVAIR met primary endpoint
- Sell Rating for Merck & Company Amid Vaccine Policy Uncertainty and Strategic Delays
- Positive Outlook on Merck & Co. Stock Amid Stability in Gardasil Dosing Recommendations