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FDA Grants Longeveron Orphan Drug Designation for Lomecel-B in Infants with Hypoplastic Left Heart Syndrome AmericanPharmaceuticalReview
December 07, 2021
Longeveron Inc., a clinical-stage biotechnology company developing cellular therapies for chronic aging-related and certain life-threatening conditions, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD)
Lomecel-B Approved for Compassionate Use for Child with Hypoplastic Left Heart Syndrome americanpharmaceuticalreview
March 19, 2021
Longeveron announced the U.S. Food & Drug Administration (FDA) has granted expanded access approval for the administration of Longeveron’s investigational cell therapy Lomecel-B to a child with Hypoplastic Left Heart Syndrome (HLHS).
Longeveron Expands Enrollment Criteria for Trial Evaluating Lomecel-B Infusion ARDS due to COVID-19 americanpharmaceuticalreview
March 11, 2021
Longeveron announced enrollment criteria for its Phase 1 Acute Respiratory Distress Syndrome (ARDS) RECOVER trial has been expanded to include mild ARDS, in addition to moderate and severe ARDS. Previously, only ARDS patients intubated with ...