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$Mesoblast(MESO.US)$ Mesoblast Nears FDA Approval for Key Therapies
Mesoblast (MESO) has released an update.
Mesoblast Limited has reported significant progress in its discussions with the FDA, receiving guidance on licensure paths for its innovative therapies, remestemcel-L for pediatric graft versus host disease, and rexlemestrocel-L for end-stage heart failure. The company is poised to resubmit its Biologics License Application for remestemcel-L and seeks an accelerated approval for rexlemestrocel-L following promising study results. With a strengthened balance sheet and cost containment strategies, Mesoblast continues to advance its late-stage product candidates, targeting severe inflammatory conditions.
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