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CDER approves 50 novel products in 2024, five less than the 55 products approved in 2023 and well above the 10-year rolling annual...[ Price : $8.95]
FDA approves Ionis Spinraza as the first drug approved to treat children and adults with spinal muscular atrophy.[ Price : $8.95]
FDA says Alcon recalled one lot of Systane Ultra PF eye drops due to potential fungal contamination.[ Price : $8.95]
FDA approves Galdermas Nemluvio to treat some dermatitis patients aged 12 and older.[ Price : $8.95]
FDA approves Array BioPharmas Braftovi to treat some patients with metastatic colorectal cancer with a specific mutation.[ Price : $8.95]
FDA posts a final guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under...[ Price : $8.95]
FDA issues a draft guidance entitled Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Under...[ Price : $8.95]
FDA clears an Inogen 510(k) for the Simeox 200 Airway Clearance Device.