FDA India director Sarah McMullen says the agency is working to increase drug inspections in India and station additional investigators there.
Viking Therapeutics says its Phase 2 clinical trial of obesity drug VK2735, a dual agonist of glucagon-like peptide 1 and glucose-dependent insulinotr...
FDA issues a safety alert advising patients and healthcare providers about the potential risk of serious complications with Holigics BioZorb Marker an...
FDA researchers say a wide range of treatments for rare pediatric diseases have been developed in the 10 years since the pediatric disease priority re...
FDA accepts for review a BeiGene BLA for Tevimbra (tislelizumab) for combination use with chemotherapy in treating locally advanced unresectable or me...
FDA sends Minerva Neurosciences a complete response letter on its NDA for roluperidone, indicated for treating negative symptoms in patients with schi...
Former FDA associate chief counsel and CDER policy advisor Eva A. Temkin joins Paul Hastings as chair of the firms FDA practice.
Vyaire Medical recalls its AirLife Adult Manual Resuscitator and oxygen reservoir bag due to out-of-specification components used in manufacturing.
