Curium – New Drug Application for ‘Radioequivalent’ Lutetium 177 Dotatate PRRT
Update 1st July 2026. This approval was being held up by legal processes after a patent dispute brought by Novartis subsidiary Advanced Accelerator Applications over their respective lutetium-177 (Lu-177) dotatate products. However, a court victory on 17th June 2026 paves the way for Curium’s plans to provide targeted radioligand therapy to U.S. patients with GEP-NETs. A new PDUFA (Prescription Drug User Fee Act) is awaited. (St. Louis. – 09 July 2024) – Curium, a world leader in nuclear medicine, announced today that it has submitted its 505(b)(2) New Drug Application for Lutetium Lu 177 Dotatate PRRT, which, if approved by…