FDA clears an Agfa 510(k) for its DR 800 multi-purpose imaging system.
FDA approves a MannKind supplemental NDA for Afrezza (insulin human) inhalation powder to remove a required Risk Evaluation and Mitigation Strategy co...
FDA accepts for review a Sanofi Pasteur supplemental BLA to expand the age indication of its Fluzone Quadrivalent (influenza vaccine) 0.5 mL dose to i...
AbbVie files a BLA for risankizumab, an investigational interleukin-23 inhibitor being evaluated for treating patients with moderate to severe plaque ...
FDA issues a draft guidance explaining its regulatory approach and policy for multiple function medical device products.
FDA issues an FDA-483 with seven inspection observations from an inspection at Indias Suven Life Sciences Limited.
FDA grants Omeros Corp. a breakthrough therapy designation for OMS721 for treating patients with high-risk hematopoietic stem cell transplant-associat...
FDA warns about the rare but serious potential for hemophagocytic lymphohistiocytosis in patients taking Lamictal.