FDA Action Update, October 2025: Clearance, Acceptance, and Extension

Catch up on any of the neurology headlines you may have missed in September 2026, compiled into 1 place by the NeurologyLive® team.

Phase 3 ARISE trial results show solengepras 150 mg significantly reduced OFF time and improved motor and non-motor symptoms in Parkinson disease.

An MDS 2026 plenary speaker discusses the evolving role of infusion therapies, deep brain stimulation, and focused ultrasound in Parkinson disease, including when to consider device-aided therapies and how treatment selection can be individualized.

Carlos Cruchaga, PhD, director of the NeuroGenomics and Informatics Center at Washington University, discusses emerging blood-based biomarkers for monitoring biological and cognitive responses to lecanemab treatment in Alzheimer disease.

Phase 2a trial results showed 800 mg vutiglabridin significantly improved motor symptom scores compared with placebo in early-stage Parkinson's disease.

Investigational oral dopamine agonist prodrug boosts good ON-time, cuts OFF-time and dyskinesia, and reduces levodopa in advanced Parkinson disease, as phase 2 begins.

The associate vice president of clinical research at the Parkinson's Foundation discussed a large-scale replication of rs3115534-G, a noncoding GBA1 variant tied to Parkinson disease in people of African ancestry.

Benjamin Walter, MD, MBA, discusses how advances in biomarker testing and genetic characterization are informing Parkinson disease care, alongside developments in adaptive deep brain stimulation and efforts to identify disease earlier.