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FDA issues a draft guidance with recommendations to help master file holders determine to which Center to submit cross-Center master files.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...
Novo Nordisk reports favorable Phase 2 data for its investigational dual-action obesity and diabetes drug amycretin, showing significant reductions in...
A new study of FDA advisory committee meetings reveals that a substantial portion of public speakers support drug approval, and many have financial co...
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.
