An Associated Press report says an upcoming FDA advisory committee meeting to consider an Amylyx drug to treat ALS may raise issues similar to those p...
PharmaTher says it will work with FDA toward a Phase 3 trial of its ketamine infusion to treat levodopa-induced dyskinesia in Parkinsons patients.
CDER Office of Manufacturing Quality branch chief Maan Abduldayem outlines the Centers Top Recent Warning Letter Citations (FY 2019 to FY 2021).
Federal Register notice: FDA renews its Obstetrics, Reproductive and Urologic Drugs Advisory Committee for an additional two years.
FDA clears an Artio Medical 510(k) for its Solus Gold Embolization Device for peripheral vascular occlusion.
FDA issues a complete response letter saying it cannot approve at this time a Takeda prior approval supplement for its Natpara hypoparathyroidism medi...
Federal Register notice: FDA makes available a final guidance entitled Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4.
Federal Register notice: FDA changes the name and function of the Bone, Reproductive and Urologic Drugs Advisory Committee to Obstetrics, Reproductive...