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
WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states
These building blocks are essential to modern therapeutics, including fast-growing GLP-1 treatments for weight loss and diabetes
GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization
The Phase-2b study is a randomized, double-blind, placebo-controlled trial that will enroll approximately 195 patients across 35 sites in the USA
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals
The Phase 3 HER2CLIMB-05 trial showed a 35.9% reduction in risk for patients treated with TUKYSA
The multi-partner team will integrate new technologies across the entire mAb production workflow, from cell line development to purification
The FDA aims to make a decision by April 8, 2026
Retatrutide, tested at 9 mg and 12 mg doses alongside diet and exercise, met all primary and key secondary endpoints
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