Lenmeldy™ (atidarsagene autotemcel) – New orphan drug approval
March 18, 2024 - The FDA announced the approval of Orchard Therapeutics’ Lenmeldy (atidarsagene autotemcel), for the treatment of children with pre-symptomatic late infantile (PSLI), presymptomatic early juvenile (PSEJ) or early symptomatic early juvenile (ESEJ) metachromatic leukodystrophy (MLD).