Manufacturing news briefs – stories you might have missed

FDA accepts Mesoblast’s responses  Biotech company Mesoblast has announced that the United States Food and Drug Administration (FDA) has accepted Mesoblast’s Biologics License Application (BLA) resubmission for Ryoncil (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). According to a statement, the FDA considers the resubmission to be a complete…

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…