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
At the trial’s pre-specified interim analysis, giredestrant achieved a hazard ratio of 0.70, marking a statistically significant improvement in invasive disease-free survival
The company will respond to the US FDA within the stipulated timelines
Glenmark's Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial is bioequivalent and therapeutically equivalent to the reference listed drug
The Phase-2b study is a randomized, double-blind, placebo-controlled trial that will enroll approximately 195 patients across 35 sites in the USA
GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization
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 Healey ALS Platform Trial is a multicenter, double-blind, placebo-controlled
The multi-partner team will integrate new technologies across the entire mAb production workflow, from cell line development to purification
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