Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.
Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.
Read this article in Pharmaceutical Technology’s October 2020 Regulatory Sourcebook
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.