A California federal judge rejects FDA regulation of a stem cell clinic, saying it is engaged in the practice of medicine.
Novo Nordisk agrees to pay $6.3 million to resolve allegations that it violated the False Claims Act by selling its NovoFine needles to U.S. governmen...
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Two major drug trade associations ask for changes in an FDA draft guidance on risk management plans to mitigate drug shortages.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...
