The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
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 company has unveiled the results of pirtobrutinib from its BRUIN CLL-313 study
The agreement pairs Croda’s global footprint and “smart science” approach with Amino’s precision manufacturing capabilities
The EMBOLD study evaluated relutrigine for patients with SCN2A and SCN8A developmental and epileptic encephalopathies
The center will offer training to super-specialist doctors and healthcare professionals in various fields
The drug, intended for chronic weight management alongside diet and exercise, is now under the FDA’s new CNPV expedited review pathway
Owlet’s push comes as parents demand smarter, more dependable nursery tech
The Signia Circular Stapler is the only circular stapler on the market with integrated leak testing and features designed to minimize risk
The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study
Subscribe To Our Newsletter & Stay Updated
