Reported Earlier, Mesoblast Resubmits Biologics License Application (BLA) For Ryoncil To FDA, Targeting Treatment For Children With SR-aGVHD

FDA granted remestemcel-L Fast Track designation, a process to facilitate the development and expedited review of therapies for serious conditions that fill unmet medical needs, and Priority Review designation, which is given to drugs that treat a serious condition and provide a significant improvement in safety or effectiveness over existing treatments.

The BLA resubmission upon acceptance is expected to have a review period of between two and six months from receipt.