Long-awaited FDA approval for Mesoblast marks a first in the U.S.

At long last, Mesoblast has gained its first FDA approval — nearly a decade after Japan’s regulatory agency approved the same product, an allogeneic bone marrow-derived mesenchymal stromal cell therapy for GvHD.

On Thursday, after multiple regulatory setbacks over the years, Ryoncil remestemcel-L gained approval by the U.S. agency to treat steroid-refractory acute graft-versus-host disease in pediatric patients. Approval of the product from Australian regenerative medicine company Mesoblast Ltd. (ASX:MSB; NASDAQ:MESO) marks the first mesenchymal stromal cell (MSC) therapy approved by FDA...