Charles River Laboratories names former FDA principal deputy commissioner Namandj N. Bumpus as senior vice president and chief scientific and innovati...
FDA sends an untitled letter to Altor BioScience, alleging that promotional Web pages for bladder cancer drug Anktiva are false or misleading and viol...
FDA and the European Medicines Agency publish their collaborative 10 guiding principles for using artificial intelligence in drug development and eval...
FDA warns Austell, GA-based Anatomy Supply Partners about multiple types of violations in its manufacturing of the Safe-T-Fill Micro Capillary Collect...
FDA clears an iotaMotion 510(k) for an expanded pediatric indication for its iotaSOFT robotic-assisted cochlear implant insertion system.
Taxpayers Protection Alliance executive director Ross Marchand says FDA needs to change its risk-averse approach to drug evaluation and accelerate app...
FDA warns Winder, GA-based Winder Laboratories about repeat CGMP violations in its manufacturing of finished drugs.
FDA accepts for priority review an Argenx supplemental BLA seeking to expand the use of its myasthenia gravis drug Vyvgart.
