Posted by Michael Wonder on 12 Jan 2026
FDA accepts new drug application for pimicotinib for the treatment of tenosynovial giant cell tumoir
12 January 2026 - Merck announced today that the US FDA has accepted the company’s new drug application for pimicotinib as a systemic treatment for patients with tenosynovial giant cell tumour.
The application is based on the primary results and longer-term follow-up of the global Phase 3 MANEUVER study, which demonstrated deep and durable tumour responses and meaningful improvements in clinical outcomes with pimicotinib.
