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
WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states
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 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
The new centre brings advanced corneal procedures pioneered in India
The U.S. oncology market is projected to soar from $81 billion in 2025 to $212 billion by 2034
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