FDA approves Genzymes Xenpozyme to treat acid sphingomyelinase deficiency in children and adults.
Two major drug trade associations ask for changes in an FDA draft guidance on risk management plans to mitigate drug shortages.
FDA clears a Baxter International 510(k) clearance of its new Novum IQ syringe infusion pump with Dose IQ Safety Software.
Amneal Pharmaceuticals files an NDA for IPX203, a novel formulation of carbidopa/levodopa extended-release capsules for treating Parkinsons disease.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Allergans Ubrelvy (ubrogepant), indicated for t...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for TherOxs PMA for the TherOx Downstream System, i...
Three patient advocacy groups sue HHS and the Centers for Medicare and Medicaid Services over their support for insurance companies and pharmacy benef...
Beam Therapeutics says it will complete studies requested by FDA as part of a clinical hold on a Beam-201 cancer treatment IND and submit its response...
