Federal Register notice: FDA withdraws approval of two NDAs held by Guerbet Group after being notified that the products were no longer marketed.
FDA clears an Allergan 510(k) for TrueTear Intranasal Tear Neurostimulator, a handheld device developed to temporarily increase tear production during...
FDA releases its latest batch of Warning Letters that includes Divis Laboratories, Exact-Rx and Teva Pharmaceutical and Chemical.
Lonza receives an FDA Warning Letter after an inspection at the firms Walkersville, MD bioscience solutions manufacturing plant.
Federal Register notice: FDA announces a 5/17 e Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee meeting where pan...
FDA Review editor Jim Dickinson further analyzes the unprecedented electrifying swiftness with which a normally snails-pace FDA acted against a medica...
FDA accepts for review a Santen Pharmaceutical NDA for intravitreal sirolimus for treating non-infectious uveitis of the posterior segment.
FDA approves a Sanofi and Regeneron Pharmaceuticals supplemental BLA for a once-monthly, 300 mg dose of Praluent (alirocumab) injection for treating a...