Reported about 20 hours ago
Merck & Co., Inc. has received priority review from the FDA for its supplemental Biologics License Application for WINREVAIR, previously approved in 2024 for pulmonary arterial hypertension. This application aims to update the product label based on promising results from the Phase 3 ZENITH trial, which showed a significant reduction in major morbidity and mortality events for patients. The FDA has set an action date of October 25, 2025.
Source: YAHOO