FDA clears an Inogen 510(k) for the Simeox 200 Airway Clearance Device.
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 approves Array BioPharmas Braftovi to treat some patients with metastatic colorectal cancer with a specific mutation.
FDA approves Ionis Spinraza as the first drug approved to treat children and adults with spinal muscular atrophy.
FDA posts a draft guidance entitled Considerations for Including Tissue Biopsies in Clinical Trials.
FDA releases a draft guidance entitled Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-Making for Drug and B...
Neumora Therapeutics says its Phase 3 KOASTAL-1 Study of navacaprant for treating major depressive disorder missed its primary endpoint and a key seco...
