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

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

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

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

Rahway, New Jersey Thursday, July 3, 2025, 09:00 Hrs [IST] ...

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 ...

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.

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

Merck's Winrevair reduced clinical worsening in PAH patients in the Phase 3 HYPERION trial, building on prior positive study ...

The drug, which will sell under the name Winrevair, treats a condition called pulmonary arterial hypertension that affects nearly 40,000 people in the U.S. In 2021, Merck paid $11.5 billion for ...