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.
FDA Clears Lumipulse Plasma Ratio as First Blood Test for Diagnosing Alzheimer Disease
May 16th 2025The FDA approved Fujirebio's Lumipulse G p-tau217/β-Amyloid 1-42 Plasma Ratio as the first in vivo blood test for early Alzheimer’s detection, demonstrating high diagnostic accuracy with strong correlations to amyloid PET and CSF test results.
FDA Approves FcRn Blocker Nipocalimab for Broad Forms of Generalized Myasthenia Gravis
April 30th 2025Administered intravenously in a single-dose vial, nipocalimab becomes the second FDA-approved therapy for common forms of generalized myasthenia gravis, and the first for younger patients living with the disease.
FDA Clears INTRABEAM 700 as Supportive Device for Intraoperative Radiation Therapy
April 29th 2025The ZEISS INTRABEAM 700 advances neurosurgical oncology by enabling precise intraoperative radiotherapy delivery, improved workflow efficiency, and enhanced collaboration between neurosurgeons and oncologists.
FDA Grants Authorization to Epiminder’s Implantable Continuous EEG Monitor for Epilepsy Treatment
April 23rd 2025The system has been previously recognized with breakthrough device designation by the FDA, emphasizing its potential to enhance epilepsy care through more effective diagnosis and management.
FDA Approves CT-132 as First Digital Therapeutic for Preventive Treatment of Episodic Migraine
April 15th 2025CT-132, an approach that aims to reduce brain hypersensitivity, becomes the first marketed digital treatment to prevent migraine, intended to be used with other previously approved medications.
DMD Community Eyes First Cell Therapy Approval Following FDA’s Acceptance of Deramiocel Submission
March 4th 2025With a scheduled PDUFA date of August 31, 2025, deramiocel looks to become the first marketed treatment for cardiomyopathy in DMD, one of the leading causes of death in this patient population.
FDA Approves Expanded Use of Eculizumab for Pediatric Myasthenia Gravis
March 4th 2025Originally approved in 2007, eculizumab (Soliris; Alexion/AstraZeneca) is now available to treat both adult and pediatric patients with generalized myasthenia gravis, becoming the first available option for younger patients with the disease.
FDA Approves Tenecteplase for Acute Ischemic Stroke
March 3rd 2025The thrombolytic treatment, branded as TNKase and approved for adults, is administered as a 5-second IV bolus, upping the speed and simplicity of the 60-minute infusion of the previously approved alteplase (Activase; Genentech).
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.
