Former FDA commissioner Scott Gottlieb says Congress needs to design a framework for the modern, efficient regulation of medical artificial intelligen...
Citing payor management concerns, Indivior says it is discontinuing sales and marketing for schizophrenia drug Perseris (risperidone).
Bausch+Lombs Synergetics unit recalls its I-PACK Injection Kit with Drape, which is used for the administration of an intravitreal (back of the eye) i...
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...
