The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
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
Retatrutide, tested at 9 mg and 12 mg doses alongside diet and exercise, met all primary and key secondary endpoints
The new centre brings advanced corneal procedures pioneered in India
The companies aim to expand treatment options for millions living with metabolic disorders
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
This is the first approval of a prescription transdermal dosage Form in the European markets from this facility
Subscribe To Our Newsletter & Stay Updated
