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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 ...
Longeveron Completes Enrollment for Alzheimer's Disease Study americanpharmaceuticalreview
December 24, 2019
Longeveron has completed enrollment in its Phase 1 Alzheimer's disease trial. This randomized, double-blind, placebo-controlled study is designed to evaluate the safety and ...