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 Dose Expansion of Catalyst's Amifampridine for Lambert-Eaton Myasthenic Syndrome
Published: June 3rd 2024 | Updated: June 7th 2024The FDA approval of the increased maximum daily dose for amifampridine offers clinicians and patients greater flexibility in treatment regimens for the management of Lambert-Eaton myasthenic syndrome.
FDA Grants Rare Pediatric Disease Designation to DMD Gene Therapy Candidate SGT-003
May 16th 2024Solid Biosciences is expecting to provide initial safety data on SGT-003 from the first couple of pediatric patients with Duchenne muscular dystrophy enrolled in the phase 1/2 INSPIRE Duchenne trial in mid-2024.
FDA Allows Additional Enrollment to Foralumab Expanded Access Program
May 4th 2024To date, treatment with foralumab has shown promising results in stabilizing or improving clinical measures without serious adverse effects among patients with non-active secondary progressive multiple sclerosis.
FDA Approves Medtronic’s Inceptiv Closed-Loop Spinal Cord Stimulator
Published: April 30th 2024 | Updated: May 2nd 2024The FDA approval of Medtronic’s spinal cord stimulator makes it the first on the market to offer a closed-loop feature that senses biological signals along the spinal cord and automatically adjusts stimulation in real time for chronic pain.
FDA Agrees to New Specialized Protocol for Phase 3b Study of ALS Agent NurOwn
April 10th 2024The new double-blind, placebo-controlled study includes approximately 200 patients with ALS who will undergo a single bone marrow aspiration procedure to procure the mesenchymal stem cells that will be used to manufacture each participant’s NurOwn treatment for the trial.
FDA Approves Alexion's Ravulizumab-cwvz for Neuromyelitis Optica Spectrum Disorder
March 25th 2024The approval is supported by phase 3 data which showed ravulizumab-cwvz met its primary end point of time to first on-trial relapse, with no relapses observed in 58 patients with NMOSD over a median treatment duration of 73 weeks.