Posted by Michael Wonder on 01 Dec 2020
Kadmon announces FDA acceptance of NDA for belumosudil in patients with chronic graft versus host disease
30 November 2020 - Application being evaluated Under FDA's Real-Time Oncology Review and Project Orbis pilot programs.
Kadmon today announced that the U.S. FDA has accepted the Company's new drug application for belumosudil (KD025), the Company's rho-associated coiled-coil kinase 2 inhibitor, for the treatment of patients with chronic graft versus host disease.
The FDA granted priority review for the application for belumosudil, which provides for a six-month review, and assigned a Prescription Drug User Fee Act target action date of 30 May 2021.
