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...
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.
