Posted by Michael Wonder on 01 Apr 2020
FDA accepts Mesoblast's biologics licence application for Ryoncil and agrees to priority review
1 April 2020 - Mesoblast today announced that the United States FDA has accepted for priority review the Company’s biologics license application filing for Ryoncil (remestemcel-L), its allogeneic cell therapy for the treatment of children with steroid-refractory acute graft versus host disease.
The FDA has set a Prescription Drug User Fee Act action date of 30 September 2020, and if approved, Mesoblast will make Ryoncil immediately available in the United States.
