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 multi-partner team will integrate new technologies across the entire mAb production workflow, from cell line development to purification
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 product will be marketed by Dr. Reddy's Laboratories Inc.
The Phase-2b study is a randomized, double-blind, placebo-controlled trial that will enroll approximately 195 patients across 35 sites in the USA
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
Subscribe To Our Newsletter & Stay Updated