Mesoblast wins FDA approval for new potency assay for Ryoncil commercial lots
MSB•Mesoblast received FDA clearance to use its new TIBA potency assay for commercial release and stability monitoring of Ryoncil lots.
1. Assay cleared for Ryoncil
The assay is intended to help flag potency shifts linked to manufacturing changes or new production sites. Ryoncil is FDA-approved for steroid-refractory acute graft-versus-host disease in patients aged 2 months or older.
