The FDA has granted Orphan Drug designation to Longeveron Inc's
(Get Free Alerts for LGVN) lead investigational product Lomecel-B for Hypoplastic left heart syndrome (HLHS).- Lomecel-B is a cell-based therapy product derived from culture-expanded medicinal signaling cells (MSCs), sourced from the bone marrow of young, healthy adult donors.
- See here Benzinga's Full FDA Calendar.
- HLHS is a congenital disability that affects normal blood flow through the heart. As the baby develops during pregnancy, the left side of the heart does not form correctly.
- Hypoplastic left heart syndrome is one type of congenital heart defect.
- Last month, The FDA granted Rare Pediatric Disease (RPD) designation Lomecel-B for Hypoplastic Left Heart Syndrome.
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