Drug Approval | December 14, 2025
FDA completes inspection of SMS Pharma’s Vizag facility
The inspection concluded with one minor observation in Form 483
The inspection concluded with one minor observation in Form 483
Updated results from the EMBER-3 study showed that the drug -- Inluriyo (imlunestrant) -- as a standalone treatment cut the risk of progression or death by 38%
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
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 multi-partner team will integrate new technologies across the entire mAb production workflow, from cell line development to purification
Retatrutide, tested at 9 mg and 12 mg doses alongside diet and exercise, met all primary and key secondary endpoints
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