FDA approves an expanded indication for Janssens Xarelto to include patients with recent lower extremity revascularization under specific circumstance...
FDA released the FDA-483 with seven observations from an inspection at Indias Jubilant Generics drug manufacturing firm.
FDA says CDER researchers have developed a three-step process to promote viral clearance during continuous manufacturing of therapeutic proteins.
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Federal Register notice: FDA posts a draft guidance entitled Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA....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...