FDA grants Baxter International an emergency use authorization for the Oxiris filter set to treat patients who have confirmed Covid-19 and have been a...
CNS Pharmaceuticals seeks an FDA orphan drug designation for berubicin for treating glioblastoma.
Kaiser Health News says FDA has increased seizures of drugs being imported into the U.S. from Canada and other countries by individual consumers.
FDA says Trividia Health is recalling a single True Metrix Air blood glucose meter that has an incorrect factory-set unit of measure.
Federal Register notice: FDA extends the comment period on a 1/30-published draft guidance entitled Interpreting Sameness of Gene Therapy Products Und...
Federal Register notice: FDA makes available a final guidance on nonbinding feedback after a medical device inspection.
FDA associate commissioner for minority health Richardae Araojo reviews progress made in the last years by the Office of Minority Health and Health Eq...
FDA accepts for review a Mallinckrodt NDA for terlipressin, indicated for treating hepatorenal syndrome type 1.