The Biotechnology Innovation Organization says it supports FDA efforts to promote stakeholder discussion on the role of artificial intelligence and ma...
Novo Nordisk says its Wegovy cut the risk of major adverse cardiovascular events by 20% in overweight or obese adults in the SELECT trial.
FDA approves a Boston Scientific PMA for the POLARx Cryoablation System for treating patients with paroxysmal atrial fibrillation.
FDA approves a Sage Therapeutics NDA for Zurzuvae (zuranolone), an oral drug for treating postpartum depression in adults.
FDA issues a draft guidance entitled Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry.
FDA approves an Astellas Pharmas Izervay (avacincaptad pegol intravitreal solution) for treating geographic atrophy secondary to age-related macular d...
FDA clears an Abbott 510(k)for its Alinity h-series hematology system for use by laboratories to run complete blood counts.
Federal Register notice: FDA determines that Cubist Pharmaceuticals Cubicin and Cubicin RF (daptomycin) powder for injection were not withdrawn due to...
