Ascendis Pharma files an NDA for TransCon PTH, an investigational prodrug designed to restore parathyroid hormone (PTH [1-34]) to physiological levels...
FDA authorizes Modernas and Pfizer-BioNTechs updated (bivalent) Covid-19 vaccines for use as a single booster dose at least two months following prima...
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Two major drug trade associations ask for changes in an FDA draft guidance on risk management plans to mitigate drug shortages.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.
