[ Price : $8.95]
FDA extends by three months its review of an Ascendis Pharma NDA for TransCon CNP (navepegritide) and its use for treating childre...[ Price : $8.95]
FDA releases the form FDA-483 with nine observations from an inspection at Frances Fareva Amboise drug manufacturing facility.[ Price : $8.95]
Three Ropes & Gray attorneys outline FDAs new plausible mechanism pathway for approving personalized therapies and discuss questio...[ Price : $8.95]
Baxter recalls (Class 1) its Life2000 Ventilation System after the company discovered a cybersecurity vulnerability.[ Price : $8.95]
FDA warns Chinas Hong Qiangxing Shenzhen Electronics about Quality System violations in its production of several medical devices....[ Price : $8.95]
FDA warns Baton Rouge, LA-based Owen Biosciences about CGMP violations in its production of finished drugs as a contract manufactu...[ Price : $8.95]
FDA approves Novartis Itvisma (onasemnogene abeparvovec-brve), a new formulation of a gene therapy for a broader age of spinal mus...[ Price : $8.95]
FDA issues a draft guidance with recommendations to help master file holders determine to which Center to submit cross-Center mast...