FDA issues an FDA-483 detailing 11 observations from an inspection at the Atlas Pharmaceuticals outsourcing facility.
FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes 16-0 to recommend approval of Novo Nordisks once-weekly semaglutide to improve glycem...
Attorney Ritte van Laack says a New York federal court dismissed an FTC suit alleging that Quincy Bioscience made unsubstantiated advertising claims f...
FDA approves Nexus Pharmaceuticals procainamide HCl injection as a multi dose vial containing 1,000 mg per 2 mL or as a multi dose vial containing 1,0...
A CDRH webinar on real-world evidence responds to questions and comments posed in response to the Centers recent guidance.
FDA says Austrias Octapharma has withdrawn two lots of its octagam 10% from the market after consulting with FDA.
Attorney Michelle Yeary says a Massachusetts federal court ruled that a suit alleging that drug companies packaged eye drops in dispensers that releas...
Merck says its California viral and gene therapy manufacturing facility passed an FDA inspection.