Mesoblast submits application for key drug approval

Cellular medicines developer Mesoblast has resubmitted its BLA for approval of Ryoncil (remestemcel-L) in the treatment of children with SR-aGVHD. Remestemcel-L is being developed for inflammatory diseases in children and adults, including steroid-refractory acute graft versus host disease, and biologic-resistant inflammatory bowel disease. It was only in March that the Food and Drug Administration decided…

Mesoblast gets FDA go ahead for pediatric drug

The US Food and Drug Administration has told biotechnology company Mesoblast that it now has sufficient clinical data to support a submission to approve the company’s remestemcel-L drug for treatment of pediatric patients. Remestemcel-L is being developed for inflammatory diseases in children and adults, including steroid-refractory acute graft versus host disease, and biologic-resistant inflammatory bowel…