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Merck (NYSE:MRK) announced Wednesday that the U.S. Food and Drug Administration (FDA) granted priority review for its request ...
Merck & Co., Inc. (NYSE:MRK) is one of the 10 Best Dip Stocks to Buy According to Billionaires. On July 2, Merck & Co., Inc. (NYSE:MRK) announced that the FDA has accepted and granted priority review ...
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug ...
Rahway: Merck, known as MSD outside of the United States and Canada, has announced that the U.S. Food and Drug Administration ...
ZENITH was the first of its kind in PAH to focus purely on hard outcomes like death, transplant, or long-term hospitalization ...
Welcome to Fierce Pharma's regulatory tracker for the second half of 2025. | In this tracker, Fierce Pharma is recording the ...
Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% ...
Winrevair was approved by the FDA to treat PAH, WHO Group 1, in March 2024 based on data from the STELLAR study. The drug was approved for a similar use in the EU in August 2024.
Merck's Winrevair gains FDA priority review for PAH label update after ZENITH trial shows major reduction in serious events and strong clinical impact.
Merck's Winrevair reduced clinical worsening in PAH patients in the Phase 3 HYPERION trial, building on prior positive study ...
FDA Grants Priority Review for WINREVAIR™ (sotatercept-csrk) to Update Label Based on Results From ZENITH Trial. Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today ...
WINREVAIR may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method ...