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...
Boehringer Ingelheim reports data from its Phase 2 survodutide study showing that up to 83.0% of adults treated with the drug achieved a statistically...
FDA approves Alvotech and Teva Pharmaceuticals Simlandi (adalimumab-ryvk) injection, an interchangeable biosimilar to AbbVies Humira.
