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190 News Found

Merck wins key EU backing to expand use of PAH Drug WINREVAIR
News | December 13, 2025

Merck wins key EU backing to expand use of PAH Drug WINREVAIR

WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states


FDA accepts Wockhardt's NDA for breakthrough antibiotic Zaynich
Drug Approval | December 02, 2025

FDA accepts Wockhardt's NDA for breakthrough antibiotic Zaynich

This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the USFDA


FDA slaps gene therapy Elevidys with boxed warning after fatal liver failures
News | November 24, 2025

FDA slaps gene therapy Elevidys with boxed warning after fatal liver failures

Elevidys came under scrutiny in June when the FDA disclosed two fatal cases in non-ambulatory boys who developed dangerously high liver enzyme levels


Merck’s WINREVAIR shows promise in phase 2 study for hard-to-treat pulmonary hypertension
Clinical Trials | November 21, 2025

Merck’s WINREVAIR shows promise in phase 2 study for hard-to-treat pulmonary hypertension

The drug is being tested for combined post- and precapillary pulmonary hypertension due to heart failure with preserved ejection fraction


Cardiol Therapeutics wins US patent protection for heart-disease drug platform
News | November 19, 2025

Cardiol Therapeutics wins US patent protection for heart-disease drug platform

The patent will lock in broad protection for the company’s lead therapy CardiolRx and its novel subcutaneous candidate CRD-38


Alexion highlights breakthrough C5 inhibition advances in gMG at 2025 AANEM and MGFA scientific sessions
Clinical Trials | October 31, 2025

Alexion highlights breakthrough C5 inhibition advances in gMG at 2025 AANEM and MGFA scientific sessions

New Phase III data on gefurulimab highlight potential as a self-administered treatment option; real-world evidence reinforces clinical benefits of Ultomiris and Soliris


Winrevair cuts risk of PAH progression by 76% in phase 3 Hyperion trial
Clinical Trials | October 01, 2025

Winrevair cuts risk of PAH progression by 76% in phase 3 Hyperion trial

Hyperion results presented at ERS 2025 and simultaneously published in the New England Journal of Medicine