Rahway: Merck, known as MSD outside of the United States and Canada, has announced that the U.S. Food and Drug Administration ...

Merck’s MRK blockbuster PD-L1 inhibitor, Keytruda, approved for several types of cancer indications, is the company's biggest ...

Merck (NYSE:MRK) announced Wednesday that the U.S. Food and Drug Administration (FDA) granted priority review for its request ...

WINREVAIR is the first activin signaling inhibitor therapy approved to treat PAH. WINREVAIR improves the balance between pro-proliferative and anti-proliferative signaling to modulate vascular ...

Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% ...

Welcome to Fierce Pharma's regulatory tracker for the second half of 2025. | In this tracker, Fierce Pharma is recording the ...

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 (NYSE:MRK) recently announced the FDA's priority review for an sBLA for WINREVAIR™ and results from its ZENITH trial, showcasing significant improvements in pulmonary arterial hypertension ...

Although Merck (NYSE:MRK) is confronted with the unavoidable Keytruda patent cliff in 2028, the company is strategically ...

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug ...

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.

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 ...