FDA News
The NeurologyLive FDA News page houses all of our coverage of FDA-related actions, from new drug approvals and advisory committee meetings to application submissions, clinical holds, trial clearances, and beyond.
The Rationale Behind Recently Approved AXS-07 Combination Therapy for Migraine: Stewart Tepper, MD
February 21st 2025The professor of neurology at the Geisel School of Medicine at Dartmouth talked about how the combination therapy involving meloxicam and rizatriptan may provide a more effective approach to treating migraine. [WATCH TIME: 6 minutes]
FDA Refuses to File Harmony’s Supplemental NDA of Pitolisant in Idiopathic Hypersomnia
February 20th 2025Marketed as Wakix, the treatment is currently approved in the United States for excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy and for EDS in pediatric patients aged 6 and older.
Reducing OFF Time in Parkinson Disease With SPN-830 Infusion Therapy: Julie Pilitsis, MD, PhD, MBA
February 13th 2025The chair of neurosurgery at the University of Arizona talked about the newly approved infusion therapy that offers continuous medication delivery to improve both motor and non-motor symptoms in Parkinson disease. [WATCH TIME: 5 minutes]
Medical Insights on the Recent Approval of AXS-07 for Acute Migraine Treatment: Stewart Tepper, MD
February 5th 2025The professor of neurology at the Geisel School of Medicine at Dartmouth shared his reaction to the recent FDA approval of AXS-07, a combination of meloxicam and rizatriptan, as a new therapy for acute migraine management. [WATCH TIME: 4 minutes]
Clinical Perspective on Newly Approved Combination Therapy for Migraine: Richard B. Lipton, MD
February 4th 2025The director of the Montefiore Headache Center at Albert Einstein College of Medicine discussed the recent FDA approval of a new migraine treatment that combines rizatriptan and meloxicam. [WATCH TIME: 5 minutes]
FDA Approves Apomorphine Infusion Device SPN-830 as New Parkinson Treatment
Published: February 4th 2025 | Updated: February 6th 2025SPN-830 is a wearable subcutaneous infusion device designed to deliver continuous treatment throughout the waking day, ensuring more consistent control of OFF time.
FDA Approves Vertex Pharmaceuticals' Suzetrigine for Acute Pain Management
Published: January 30th 2025 | Updated: February 21st 2025Suzetrigine, a selective inhibitor of the NaV1.8 sodium channel, offers an alternative opioid treatment option for patients to treat moderate to severe pain without risk of addiction.
FDA Approves Axsome Therapeutics’ AXS-07 for Migraine Treatment
Published: January 30th 2025 | Updated: February 4th 2025Findings from previous phase 3 trial showed that treatment with AXS-07 resulted in significant reductions in headache pain freedom, migraine symptoms, and rescue medication use.
FDA Removes Partial Clinical Hold on VG-3927 for Microglial Dysfunction in Alzheimer Disease
January 6th 2025Results from Vigil Neuroscience’s ongoing phase 1 trial of VG-3927 in healthy volunteers supported the continued development of the therapy as a potential once-daily oral treatment for Alzheimer disease.
FDA Places Clinical Hold on Phase 2 Study of PGN-EDO51 in Duchenne Muscular Dystrophy
December 17th 2024As of July 2024, 2 participants in the ongoing CONNECT1 study have received 4 doses of PGN-EDO51 at 10 mg/kg, which has been generally well tolerated, with initial results expected in early 2025.
Neflamapimod Receives Orphan Drug Designation by FDA for Frontotemporal Dementia
December 17th 2024Most recently reported topline data from the RewinD-LB phase 2b trial in patients with dementia with Lewy bodies showed that neflamapimod failed to meet its primary end point and secondary end points.
FDA Grants NS-050/NCNP-03 Rare Pediatric Disease Designation in Duchenne Muscular Dystrophy
December 5th 2024A recently initiated phase 1/2 trial of NS-050/NCNP-03 will assess patients with Duchenne muscular dystrophy on dystrophin production, muscle strength, mobility, and functional exercise capacity.
