A bipartisan group of six senators quizzes FDA on the potential conflicts of interest in agency contracts with McKinsey since the consulting firm also...
FDA warns Japans Toyobo Co. about a CGMP violation in its manufacturing of finished drugs.
Federal Register notice: FDA posts a draft guidance entitled Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA....
In comments to FDA, drug companies and industry organizations urge the agency to develop additional and broader guidance on patient-reported outcomes.
Citing a lack of evidence, AstraZenecas Alexion drug unit discontinues its CHAMPION-ALS Phase 3 clinical trial of Ultomiris (ravulizumab) in adults wi...
Cardinal Health recalls three models of its Monoject Saline Flush Prefilled Syringes because their plunger may pull air into the syringe after a healt...
FDA approves the first Covid-19 vaccine Pfizer-BioNTechs vaccine that is now under the trade name Comirnaty.
Federal Register notice: FDA updates its listing of product-specific draft and revised draft guidances that provide recommendations on the design of b...