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FDA issues a draft guidance explaining its regulatory approach and policy for multiple function medical device products.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.
Federal Register notice: FDA announcea a 5/17 Vaccines and Related Biological Products Advisory Committee meeting.
Washington Legal Foundation asks the Supreme Court to hear Alcons appeal of a 3rd Circuit decision granting standing to a plaintiff who claims he coul...
Federal Register notice: FDA announces a 5/11 joint Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee meeting...