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

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

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

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

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 ...

ZENITH was the first of its kind in PAH to focus purely on hard outcomes like death, transplant, or long-term hospitalization ...

Merck's Winrevair gains FDA priority review for PAH label update after ZENITH trial shows major reduction in serious events and strong clinical impact.

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

Winrevair, also known as sotatercept-csrk, is a medicine used to treat pulmonary arterial hypertension (PAH), which causes high blood pressure in the arteries that go from your heart to your lungs ...

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 ...