FDA tells Intra-Cellular Therapies that it has concerns with certain findings observed in nonclinical animal toxicology studies involving ITI-007 (lum...
FDA approves a Medtronic PMA for the Resolute Onyx Drug-Eluting Stent (DES) in 4.5 mm and 5.0 mm sizes to treat patients with large coronary anatomies...
Medical ethicist Arthur Caplan outlines steps Congress could take to improve access of terminally ill patients to experimental drugs outside clinical ...
FDA publishes an FDA-483 containing four observations from an April inspection at Nephron Pharmaceuticals.
FDA says ReFlow Medical is recalling Wingman35 crossing catheters distributed between 1/205 and 3/2016.
Senate Health, Education & Pensions Committee leaders schedule a 5/10 mark-up of S 934 Food and Drug Administration Reauthorization Act, a bill to rea...
FDA classifies as Class 1 a recall of Newport Medical Instruments Newport HT70 and Newport HT70 Plus ventilators due to a software issue that may caus...
FDA issues a final guidance on testing living donors of human cells, tissues, and cellular and tissue-based products for West Nile Virus.