FDA fails to locate the UK-based manufacturer of filthy eye drops, LightEyez, accused of manufacturing and distributing unapproved and adulterated ove...
FDA warns Mamaroneck, NY-based Delsam Pharma, and Lakewood, NJ-based EzriCare about distributing adulterated and misbranded ophthalmic products obtain...
FDA denies a Boehringer Ingelheim petition asking it to change its interpretation of strength for parenteral solutions under the Biologic Price Compet...
FDA posts a final guidance entitled Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide.
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...