FDA approves Ionis Spinraza as the first drug approved to treat children and adults with spinal muscular atrophy.
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FDA issues a draft guidance entitled Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.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 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FDA posts a draft guidance entitled Considerations for Including Tissue Biopsies in Clinical Trials.
FDA releases a draft guidance entitled Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-Making for Drug and B...
