Pediatrics

Gildeuretinol receives FDA rare pediatric disease and fast track designations for Stargardt disease treatment

Alkeus Pharmaceuticals, Inc, announced that its investigational oral therapy, gildeuretinol (ALK-001), has received Rare Pediatric Disease and Fast Track designations from the U.S. Food and Drug Administration (FDA) for treating Stargardt disease. It has previously been granted Breakthrough Therapy and Orphan Drug designations. At the 2024 American Academy of Ophthalmology...