Brain HealthFDA Approves Four Neurological Drugs Targeting Alzheimer's, Glioma, and Rare Disease
The FDA has approved several significant neurological therapies in recent months. Leqembi (lecanemab) received full traditional approval for early Alzheimer's disease in patients with confirmed amyloid pathology, upgrading from its earlier accelerated status. Kisunla (donanemab) also gained approval for Alzheimer's with a revised dosing schedule. Dordaviprone (Modeyso) received accelerated approval for diffuse midline glioma with an H3 K27M mutation in patients whose disease progressed after prior therapy. Additionally, Avlayah (tividenofusp alfa) was approved for neurologic manifestations of Hunter syndrome in pediatric patients. Together, these approvals represent meaningful advances across Alzheimer's disease, rare pediatric neurological conditions, and aggressive brain tumors, signaling an active period for FDA neurology decisions.
