News | December 13, 2025
EMA backs Eylea 8 mg for retinal vein occlusion
The positive CHMP opinion is supported by results from the Phase III QUASAR trial
The positive CHMP opinion is supported by results from the Phase III QUASAR trial
WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states
The innovation -- UPM Circular Renewable Black -- is the world’s first bio-based, near-infrared (NIR) detectable, carbon-negative black
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
Retatrutide, tested at 9 mg and 12 mg doses alongside diet and exercise, met all primary and key secondary endpoints
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 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
Subscribe To Our Newsletter & Stay Updated
