FDA approves an Akorn ANDA for azelastine hydrochloride nasal spray, 0.15%, indicated for relieving symptoms of seasonal allergic rhinitis and perenni...
FDA clears a Vyaire Medical 510(k) for two of its latest pulmonary function testing technologies: Vyntus ONE and Vyntus BODY with SentrySuite Software...
Oklahoma county judge Thad Balkman rules against Johnson & Johnson and orders it to pay $572 million in the first ruling in the U.S. holding a drugmak...
FDA Review posts the Federal Register notices for the week ending 8/23/2019.
FDA Review posts product approval summaries for the week ending 8/29/2014
FDA grants Miracor Medical a breakthrough device designation for its PiCSO Impulse System for treating ST-elevated myocardial infarction patients.
FDA clears a Drawbridge Health 510(k) for the OneDraw A1C Test System, which comprises the OneDraw Blood Collection Device and the OneDraw A1C Test.