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Mesoblast Advances FDA Review for Rexlemestrocel-L in End-Stage Heart Failure
9:56am on Wednesday 1st of July, 2026 AEST
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Healthcare
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Mesoblast Advances FDA Review for Rexlemestrocel-L in End-Stage Heart Failure
9:56am on Wednesday 1st of July, 2026 AEST
Key Points
FDA issues BLA filing number for rexlemestrocel-L
Modular review requested for faster regulatory assessment
Therapy targets gastrointestinal bleeding in LVAD patients
Orphan Drug and RMAT designations enable priority review
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