FDA may adopt new requirements to enhance the safe use of pharmaceuticals and ensure that all US drugs are available when needed.
FDA Approves Novartis Oral Treatment for Adults with C3 Glomerulopathy
March 25th 2025Fabhalta (iptacopan) received a positive opinion for treatment of C3G from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and has been approved twice before by FDA.