United states food & drug administration (fda) grants mesoblast orphan-drug designation for revascor® (rexlemestrocel-l) in children with congenital heart disease

New york, feb. 14, 2024 (globe newswire) -- mesoblast limited (nasdaq:meso; asx:msb), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the united states food and drug administration (fda) has granted its allogeneic cell therapy revascor® (rexlemestrocel-l) an orphan-drug designation (odd) following submission of results from the randomized controlled trial in children with hypoplastic left heart syndrome (hlhs), a potentially life threatening congenital heart condition. this follows the rare pediatric disease designation (rpdd) granted by fda last month.
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