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

Regulators squeezed in two final approvals before the calendar change with the UK approval of Merck’s Winrevair and the FDA’s ...

UK's Medicines and Healthcare products Regulatory Agency said on Tuesday it had approved Merck's therapy to treat a rare lung ...

Shares of Merck & Co. Inc ($MRK) were in the spotlight this week after the pharmaceutical major secured regulatory approval ...

Merck's Winrevair (sotatercept) gains UK approval for PAH treatment. Key trial results highlight significant exercise ...

MSD's pulmonary arterial hypertension (PAH) drug Winrevair has been accelerating at a breakneck pace since its launch earlier this year – and data from a new phase 3 study could give it a turbo ...

RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today positive topline results from the Phase 3 ZENITH study evaluating WINREVAIR ...

After the FDA approved both combination macitentan/tadalafil (Opsynvi) and the biologic therapy sotatercept (Winrevair) for ...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Winrevair (sotatercept) to treat pulmonary ...

Publication on Dec. 12, 2024, of data analysis regarding Merck & Co. Inc.’s Winrevair (sotatercept) in Clinical Pharmacology & Therapeutics may have put investors in mind of the odds for the activin ...

Merck secured Food and Drug Administration approval for a drug widely expected to be an era-defining blockbuster for the ...

Second positive phase 3 trial adds to growing body of evidence for WINREVAIR, an activin signaling inhibitor therapy that targets an underlying cause of PAH RAHWAY, N.J.--(BUSINESS WIRE)-- Merck ...