FDA warns Chinas Hong Qiangxing Shenzhen Electronics about Quality System violations in its production of several medical devices.
FDA warns Baton Rouge, LA-based Owen Biosciences about CGMP violations in its production of finished drugs as a contract manufacturing facility.
FDA approves Novartis Itvisma (onasemnogene abeparvovec-brve), a new formulation of a gene therapy for a broader age of spinal muscular atrophy patien...
FDA issues a draft guidance with recommendations to help master file holders determine to which Center to submit cross-Center master files.
National Center for Health Research president Diana Zuckerman defends FDA advisory committees, saying they do a more thorough job of evaluating produc...
FDA releases the form FDA-483 with six observations from an inspection at the Catalent Indiana sterile drug manufacturing facility in Bloomington, IN.
FDA cites PharmaTher over alleged misleading promotional claims for its generic ketamine.
Novo Nordisk says data from two global Phase 3 trials of semaglutide (Ozempic and Wegovy) have failed to slow clinical progression in adults with earl...
