The U.S. Food and Drug Administration on Wednesday approved Mesoblast's cell therapy for treating a type of complication that occurs after a stem cell or bone marrow transplant called graft-versus-host disease (GVHD).

More than four years later—and after two rejections from the agency—Mesoblast has finally gained an endorsement from the U.S. regulator for its first approved drug.

Ryoncil (remestemcel-L) as the first mesenchymal stromal cell (MSC) therapy in the U.S. Ryoncil is the only MSC therapy approved in the U.S. for any indication and the only therapy for steroid-refractory acute graft versus host disease (SR-aGvHD) in children 2 months and older,