Golidocitinib Green Lit by China’s NMPA for Relapsed/Refractory PTCL
Dizal's Golidocitinib Trial Demonstrates Durable Benefits for r/r PTCL
SHANGHAI, Sept. 21, 2023 /PRNewswire/ -- Dizal announced today that the China National Medical Products Administration (NMPA) has granted priority review status to golidocitinib, Dizal's investigational JAK1-only inhibitor, for the treatment of relapsed or refractory peripheral T-cell lymphoma (r/r PTCL). In February 2022, golidocitinib received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the same indication, making it the first and only innovative drug in China to receive this recognition for PTCL.
SHANGHAI, Sept. 14, 2023 /PRNewswire/ -- Dizal today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for golidocitinib for the treatment of relapsed or refractory peripheral T-cell lymphoma (r/r PTCL).