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
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization
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 FDA aims to make a decision by April 8, 2026
The cobas Mass Spec solution Ionify reagent portfolio now covers therapeutic drug monitoring for immunosuppressants and antibiotics
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
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