FDA places a clinical hold on Iovance Biotherapeutics IOV-LUN-202 clinical trial, which is assessing LN-145 tumor infiltrating lymphocyte therapy in n...
FDA Webview summarizes the Federal Register notices published during our holiday break.
A KFF Health News report on a year-long investigation into the FDA 510(k) medical device clearance pathway finds significant flaws that have injured p...
FDA warns Commerce, CA-based Colonial Dames Company about repeat CGMP violations in its manufacture of misbranded and unapproved drugs.
FDA warns Solna, Sweden-based Sonesta Medical about Quality System violations in its manufacturing of three medical devices.
FDA publishes a guidance with recommendations on using digital health technologies for remote data acquisition.
FDA publishes a guidance to assist sponsors in seeking approval of new animal drugs for minor uses or minor species.
FDA requires an additional postmarketing confirmatory study for full approval of Amgens Lumakras non-small cell lung cancer treatment that obtained ac...
