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Mesoblast and FDA Align on Revascor Filing for Ischemic Heart Failure
9:59am on Tuesday 1st of July, 2025 AEST
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Healthcare
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Mesoblast and FDA Align on Revascor Filing for Ischemic Heart Failure
9:59am on Tuesday 1st of July, 2025 AEST
Key Points
FDA confirms alignment on chemistry, manufacturing, and potency assays
Agreement on design and primary endpoint for post-approval confirmatory trial
Mesoblast plans accelerated approval filing for end-stage ischemic heart failure patients with LVAD
Revascor development under Regenerative Medicine Advanced Therapy (RMAT) designation
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