FDA Approves Pediatric MS Treatment, Grants Priority Review for Ataxia-Telangiectasia Drug

The FDA's May 2026 regulatory actions included the approval of ocrelizumab for pediatric patients aged 10 and older with relapsing-remitting multiple sclerosis. Additionally, a supplemental new drug application for levacetylleucine, intended for ataxia-telangiectasia, received Priority Review status. The agency also extended its review period for a subcutaneous formulation of lecanemab for early Alzheimer's disease, indicating ongoing developments in various therapeutic areas.