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FDA issues a draft guidance entitled Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.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.
FDA approves a new indication for Lillys Zepbound to treat some obese patients with obstructive sleep apnea.
FDA says Astellas has recalled one lot each of its Prograf and Astagraf transplant medications that may contain empty capsules.
