Sage Therapeutics and Biogen decide to not seek an expanded use (major depressive disorder) for postpartum depression drug Zurzuvae (zuranolone).
Rep. Abigail Spanberger asks FDA and DEA for additional information on their efforts to address shortages of ADHD drugs.
FDA posts the establishment inspection report with seven observations from a 2023 inspection at a Boehringer Ingelheim drug manufacturing facility in ...
FDA approves the removal of an imaging contraindication on Abbotts FreeStyle Libre 2 and 3 continuous glucose monitoring systems.
Federal Register notice: FDA makes available additional revised draft product-specific guidances that provide recommendations on bioequivalence study ...
FDA raises questions to be considered at a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting discussing a Lexicon NDA for Zynquista ...
FDA and the Veterans Administration say they are partnering to open a virtual laboratory to evaluate health-related artificial intelligence applicatio...
FDA accepts for review a PTC Therapeutics NDA resubmission for Translarna (ataluren) and its use in treating nonsense mutation Duchenne muscular dystr...
