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 Approves Lecanemab Autoinjector, Marking First At-Home Treatment for Alzheimer Disease
Published: August 29th 2025 | Updated: September 2nd 2025The autoinjector, branded as Leqembi Iqlik, contains a 360 mg/1.8 mL dose administered over 15 seconds. It is expected to enhance Alzheimer treatment accessibility and offer cost savings for patients.
FDA Grants Approval of Hypoglossal Nerve Stimulation System for Obstructive Sleep Apnea Treatment
August 21st 2025The decision stemmed from the DREAM study, which found that the Genio system was effective regardless of a patient’s sleeping position, which was particularly important considering patients spend on average 35% to 40% of in a supine position.
FDA Clears HyHub and HyHub Duo Devices for Easier Administration of Immune Globulin Infusion, Hyqvia
July 21st 2025The FDA-cleared duo devices allow for a more simplified administration of the liquid medicine Hyqvia, reducing the number of steps needed to prepare for the infusion of 2 dual vial units or more.
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.
