FDA clears an Oticon Medical 510(k) for its active transcutaneous bone conduction hearing system, the Sentio System.
AbbVie submits a supplemental NDA for Rinvoq and its use in treating adult patients with giant cell arteritis.
FDA publishes draft guidances with recommendations on 510(k) submissions for dental composite resins and curing lights.
Hamilton Medical recalls its software for the Hamilton-C6 Medical Ventilator because the ventilator may fail to restart ventilation if it enters senso...
FDA says Baxter is recalling its Life2000 ventilators that were distributed in the U.S. between 8/2023 and 4/2024 due to potential battery charger don...
Federal Register notice: FDA provides notice that a patent infringement lawsuit has been filed against Amgen over its BLA submission for a biosimilar ...
Federal Register notice: FDA makes available final guidance entitled Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disor...
FDA releases the form FDA-483 with three observations issued following an inspection at the Hikma outsourcing facility in Cherry Hill, NJ.
