Posted by Michael Wonder on 12 Dec 2024
FDA grants Revescor (rexlemestrocel-L) regenerative medicine advanced therapy designation in children with congenital heart disease
5 December 2024 - Earlier this year FDA granted Revascor both rare paediatric disease designation and orphan drug designation for congenital heart disease
Mesoblast today announced the US FDA has granted its second generation allogeneic, STRO3-immunoselected, and industrially manufactured stromal cell therapy Revascor (rexlemestrocel-L) regenerative medicine advanced therapy designation following submission of results from the randomised controlled trial in children with hypoplastic left heart syndrome, a potentially life threatening congenital heart condition.
