Posted by Michael Wonder on 31 Aug 2022
US FDA grants fast track designation for Longeveron’s Lomecel-B product for treatment of hypoplastic left heart syndrome in infants
31 August 2022 - New designation may expedite FDA review and potential approval to address this life-threatening heart condition affecting approximately 1,000 babies per year.
Longeveron today announced the US FDA has granted fast track designation to Lomecel-B for the treatment of hypoplastic left heart syndrome, a rare and life-threatening congenital heart defect affecting approximately 1,000 infants per year.
