The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
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 FDA aims to make a decision by April 8, 2026
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 investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time
The company has unveiled the results of pirtobrutinib from its BRUIN CLL-313 study
The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies
Subscribe To Our Newsletter & Stay Updated
