Mesoblast wins FDA approval for new potency assay for Ryoncil commercial lots
Mesoblast received FDA clearance to use a new potency assay, TIBA, for commercial release of Ryoncil (remestemcel-L-rknd) lots. Test will support release and stability monitoring, aiming to flag potency shifts tied to manufacturing changes or new production sites. Ryoncil is FDA-approved for steroid-refractory acute gr