Posted by Michael Wonder on 24 Jul 2024
FDA accepts Mesoblast's biologics license application for Ryoncil in children with steroid-refractory acute graft versus host disease
23 July 2024 - Mesoblast announced that the US FDA has accepted its biologics license application resubmission for Ryoncil (remestemcel-L) in the treatment of children with steroid refractory acute graft versus host disease.
The FDA considers the resubmission to be a complete response and Mesoblast anticipates a decision on or before the FDA’s PDUFA goal date of 7 January 2025.
