FDA BLA approval: Lenmeldy (Catapult’s regulatory round-up – March 2024)
The FDA has approved Lenmeldy (atidarsagene autotemcel), the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD). Lenmeldy is...