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 graft-versus-host disease in patients aged 2 months or older. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Mesoblast Limited published the original content used to generate this news brief via (Ref. ID: 202609240700PRIMZONEFULLFEED9833268) on September 24, 2026, and is solely responsible for the information contained therein. (C)