Special Report: 2025 Neurology FDA Drug & Device Approvals & Clearances

Introduction
This report is intended to collate and summarize the neurologic drugs and devices that were approved or cleared by the Food and Drug Administration (FDA) in 2025. The list includes newly approved therapies, significant changes or updates to drug indications, and notable device clearances across the spectrum of neurologic practice. Read the full report on approvals and clearances online at practicalneurology.com.

Alzheimer Disease & Dementias

• Lecanemab (Leqembi; Eisai, Tokyo, Japan; Biogen, Cambridge, MA) received approval for a once monthly intravenous maintenance dosing regimen following the initial biweekly treatment phase. 
• A subcutaneous formulation of lecanemab (Leqembi IQLIK; Eisai, Tokyo, Japan; Biogen, Cambridge, MA) was also approved for weekly maintenance dosing after completion of the intravenous initiation period. 
• Donanemab (Kisunla; Eli Lilly and Company; Indianpolis, IN) received approval for a revised titration dosing schedule for use in patients with mild cognitive impairment or mild dementia stage of Alzheimer disease.
• In diagnostics, the Lumipulse G pTau217/β-Amyloid 1–42 Plasma Ratio test (Fujirebio Diagnostics, Malvern, PA) was cleared to aid in the identification of amyloid pathology in individuals aged 50 years and older presenting with signs and symptoms of cognitive decline in specialized care settings.

Headache & Pain

• A new non-opioid sodium channel blocker, suzetrigine (Journavx; Vertex Pharmaceuticals, Boston, MA), was approved for moderate to severe acute pain, representing a novel analgesic mechanism. 
• The OneRF Trigeminal Nerve Ablation System (NeuroOne Medical Technologies, Eden Prairie, MN) was cleared for radiofrequency lesioning in pain and functional neurosurgical procedures.
• The combination therapy meloxicam/rizatriptan (Symbravo; Axsome Therapeutics, New York, NY) was approved for the treatment of people with migraine.
• The FDA greenlit new delivery options for dihydroergotamine as a nasal powder (Atzumi; Satsuma Pharmaceuticals, Durham, NC) and subcutaneous auto-injection (Brekiya; Amneal Pharmaceuticals, Bridgewater, NJ).

Imaging & Testing

• CleaRecon DL (GE HealthCare, Chicago, IL) was cleared to perform 3-dimensional (3D) reconstruction of images acquired in 3D acquisition mode on X-ray interventional systems for visualization within a volume viewer environment. 
• The Delphi-MD System (QuantalX Neuroscience, Philadelphia, PA) was cleared as a noninvasive device designed to elicit, record, and display transcranial magnetic stimulation (TMS)–evoked cortical responses using EEG. 
• The Layer 7 Cortical Interface (Precision Neuroscience; New York, NY) was cleared for temporary (≤30 days) recording, monitoring, and stimulation of electrical signals on the surface of the brain.

MS & Immune Disorders

• HyHub and HyHub Duo (Takeda, Cambridge, MA) were cleared as intravascular administration sets intended to allow transfer of medication from vials without the use of a needle in home or clinical settings for patients aged 17 years and older.

Movement Disorders

• Apomorphine hydrochloride (Onapgo; Supernus Pharmaceuticals, Rockville, MD) was approved as a subcutaneous treatment for motor fluctuations in adults with advanced Parkinson disease (PD). 
• Exablate Neuro (InSightec, Miami, FL) was cleared for unilateral and staged pallidothalamic tractotomy in individuals with medication-refractory PD. 
• The Neu Health platform (Neu Health, Oxford, England, United Kingdom) was cleared for quantification of movement disorder symptoms.
• The Felix NeuroAI Wristband (Fasikl, Minneapolis, MN) was cleared to aid in tremor-related functional limitations in adults with essential tremor. 
• Medtronic Neuromodulation’s (Minneapolis, MN) Activa, Percept, and SenSight Deep Brain Stimulation Therapy System received approval for an adaptive stimulation feature. 
• Altaviva (Medtronic Neuromodulation, Minneapolis, MN), an implantable peripheral neurostimulator, was approved for treatment of urge urinary incontinence in individuals who did not respond to conservative therapies.

Neuromuscular

• Risdiplam (Evrysdi; Genentech, South San Francisco, CA) was approved as a tablet formulation for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. 
• Eculizumab (Soliris; Alexion Pharmaceuticals, Boston, MA) received approval for use in pediatric patients aged 6 years and older with generalized myasthenia gravis (gMG) who are anti–acetylcholine receptor antibody positive (AChR+).
• Efgartigimod alfa and hyaluronidase (Vyvgart Hytrulo; Argenx, Amsterdam, Netherlands) was approved as a new pre-filled syringe for the treatment of adults with gMG who are AChR+ and for those with chronic inflammatory demyelinating polyneuropathy (CIDP). 
• Nipocalimab (Imaavy; Johnson & Johnson, New Brunswick, NJ) was approved for gMG in adult and pediatric patients aged 12 years and older who are AChR+ or anti–muscle-specific tyrosine kinase antibody positive (MuSK+).
• Diazoxide choline extended-release tablets (Vykat XR; Soleno, Redwood City, CA) were approved for the treatment of hyperphagia in adults and pediatric patients aged 4 years and older with Prader–Willi syndrome. 
• A combination of doxecitine and doxribtimine (Kygevvi; UCB, Brussels, Belgium) was approved for the treatment of thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with symptom onset at or before 12 years of age.

Neuro-Oncology

• Mirdametinib (Gomekli; SpringWorks Therapeutics, Stamford, CN) was approved for adult and pediatric patients aged 2 years and older with neurofibromatosis type 1 (NF1) and symptomatic plexiform neurofibromas (PN) not amenable to complete resection. 
• Selumetinib (Koselugo; AstraZeneca, Wilmington, DE) received expanded approval to include younger pediatric patients and adults with NF1 and symptomatic inoperable PN.
• Dordaviprone (Modeyso; Jazz Pharmaceuticals, Dublin, Ireland) received accelerated approval for the treatment of adult and pediatric patients aged 1 year and older with diffuse midline glioma harboring an H3 K27M mutation and progressive disease following prior therapy. 

Sleep

• Tirzepatide (Zepbound; Eli Lilly and Company, Indianapolis, IN) received approval for use in combination with a reduced-calorie diet and increased physical activity for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity.

Stroke

• Tenecteplase (TNKase; Genentech, South San Francisco, CA) was approved for the treatment of acute ischemic stroke in adults.
• Upadacitinib (Rinvoq; AbbVie, Norht Chicago, IL) received approval for the treatment of adults with giant cell arteritis.
• The NeVasc Aspiration System (Vesalio, San Diego, CA) was cleared for revascularization in patients with acute ischemic stroke due to intracranial large vessel occlusion within 8 hours of symptom onset, including individuals who are ineligible for or who have not responded to thrombolytic therapy. 
• The Methinks CT Angiography Stroke system (Methinks Software, Barcelona, Spain) was cleared as radiologic computer-aided triage and notification software intended to assist clinicians in identifying and communicating imaging findings in patients with suspected stroke.