Neumora Therapeutics says its Phase 3 KOASTAL-1 Study of navacaprant for treating major depressive disorder missed its primary endpoint and a key seco...
CDER approves 50 novel products in 2024, five less than the 55 products approved in 2023 and well above the 10-year rolling annual average of 46 appro...
FDA approves Galdermas Nemluvio to treat some dermatitis patients aged 12 and older.
FDA says Alcon recalled one lot of Systane Ultra PF eye drops due to potential fungal contamination.
FDA posts a final guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the...
FDA issues a draft guidance entitled Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.
FDA clears an Inogen 510(k) for the Simeox 200 Airway Clearance Device.
FDA approves Novo Nordisks Alhemo as a prophylaxis for some hemophilia patients.
