FDA Neurology Digest: August 2026

This digest highlights FDA actions in August related to therapeutics and diagnostics for neurologic illness. For information on approvals in other specialties during 2026, see our FDA Drug Approvals page.First-in-Class Narcolepsy Drug ApprovedOveporexton (Orzeyful, Takeda) received approval for narcolepsy type 1 in adults — the first drug to directly restore orexin signaling, the biological deficit behind the disorder. The twice-daily tablet was associated with improvements in daytime sleepiness, cataplexy, sleep paralysis, hallucinations, and disrupted sleep in two clinical trials and had received the FDA Breakthrough Therapy designation and Priority Review.New Blood Test for Rule-In, Rule-Out Alzheimer’s Disease (AD) AssessmentThe FDA cleared the Elecsys Phospho-Tau (217P) Plasma test (Roche, developed with Eli Lilly and Company) to identify amyloid pathology in adults aged 55 years or older with signs of cognitive decline. It is the first test cleared for both rule-in and rule-out assessment using the same cutoffs across primary and specialty care, the company said in a statement.Agency OKs Alzheimer’s Test for Younger AdultsA mass spectrometry blood test to help diagnose AD received FDA clearance. PrecivityAD2 (C2N Diagnostics) is the only test currently available for adults as young as 40 years with signs of cognitive impairment, the company said in a statement. The FDA-cleared version is expected later this year, whereas a laboratory-developed version remains available now.Hunter Syndrome Therapy on HoldThe FDA placed a new clinical hold on RGX-121 (clemidsogene lanparvovec), an investigational gene therapy for Hunter syndrome, manufacturer REGENXBIO reported in a statement. The hold follows the identification of asymptomatic spinal MRI abnormalities in five participants in the ongoing CAMPSIITE trial.T-Cell Therapy for Amyotrophic Lateral Sclerosis (ALS) on Fast TrackCK0803 (Cellenkos), an allogeneic cord blood-derived regulatory T-cell therapy, received a Fast Track designation for ALS. The therapy is the first regulatory T-cell treatment to receive this designation for ALS and is currently under study in a phase 1/1b trial, the company said in a statement.Tau-Targeted Imaging Agent for AD ApprovedThe FDA approved Tauklarify (florquinitau F 18 injection; formerly MK-6240, Lantheus), a tau-targeted PET imaging agent for adults with cognitive impairment being evaluated for AD. The radiodiagnostic detects tau neurofibrillary tangle pathology, a hallmark of AD. Approval was supported by two blinded-read studies of PET images, Lantheus noted.This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.