FDA Neurology Digest: October 2026

This digest highlights FDA actions in October related to therapeutics and devices for neurologic illness. For information on approvals in other specialties during 2026, see our FDA Drug Approvals page.Generalized Myasthenia Gravis (gMG) Autoinjector ApprovedZilucoplan (Zilbrysq, UCB), a once-daily autoinjector, received approval for adults with gMG who are anti-acetylcholine receptor antibody positive. Previously available only as a prefilled syringe, the autoinjector demonstrated comparable drug exposure in a phase 1 study, while a phase 3b study of 31 adults showed that 99.8% of 449 administrations delivered a full dose. Commercial availability is expected in the first quarter of 2027, the manufacturer said in a statement.Resubmission Accepted for Spinocerebellar Ataxia (SCA) DrugThe FDA accepted a resubmitted New Drug Application for troriluzole (Vyglxia, Biohaven) for SCA, the company disclosed in a Form 8-K regulatory filing. The resubmission included new supportive analyses and addressed the agency’s November 2025 complete response letter, which cited concerns about real-world evidence and external control studies. The FDA set a first-quarter 2027 goal date and plans to convene an advisory committee meeting.Chronic Ischemic Stroke Device Study ApprovedAn investigational device exemption application for the STROKE-REWIRE pivotal study received FDA approval, NeuWire Medical announced. The study will evaluate the company’s ReWire Vagus Nerve Stimulation System in patients with chronic ischemic stroke and upper-limb dysfunction. The wireless, battery-free implant pairs stimulation with rehabilitation movements. The randomized sham-controlled trial will enroll up to 135 participants, with initiation expected in the first half of 2027.Alzheimer’s Disease (AD) Prevention Vaccine on Fast TrackAV-1959R (Nuravax), an investigational amyloid-beta vaccine, received Fast Track designation for the prevention of AD in cognitively unimpaired individuals with biomarker evidence of amyloid pathology. No preventive therapy is currently approved for this population. The designation allows more frequent FDA interaction and may make the vaccine eligible for Rolling Review, Accelerated Approval, and Priority Review if criteria are met. A phase 2 trial of about 160 adults is planned, the company said.Lupus-Related Cognitive Impairment Drug Moves ForwardThe FDA granted Fast Track designation to EG-501 (Evergreen Therapeutics) for cognitive impairment in adults with neuropsychiatric systemic lupus erythematosus, the company said in a statement. The designation was supported by the phase 2 ClearMEMory study, a 12-week, multicenter, randomized placebo-controlled trial in which the drug produced clinically meaningful improvements in objective neuropsychological function. No approved therapies exist specifically for the condition.This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.