FDA extends by three months its review of an Ascendis Pharma NDA for TransCon CNP (navepegritide) and its use for treating children with achondroplasi...
FDA releases the form FDA-483 with nine observations from an inspection at Frances Fareva Amboise drug manufacturing facility.
Three Ropes & Gray attorneys outline FDAs new plausible mechanism pathway for approving personalized therapies and discuss questions that remain about...
Baxter recalls (Class 1) its Life2000 Ventilation System after the company discovered a cybersecurity vulnerability.
FDA releases the form FDA-483 with six observations from an inspection at the Catalent Indiana sterile drug manufacturing facility in Bloomington, IN.
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...
