Take 5 minutes to catch up on NeurologyLive®'s highlights from the week ending September 18, 2026.
News|Articles|February 12, 2026
FDA Action Update, January 2026: Approvals, Acceptance, and Clearance
Author(s)Isabella Ciccone, MPH
Fact checked by: Kelly King
Catch up on any of the neurology headlines you may have missed in January 2026, compiled into 1 place by the NeurologyLive® team.
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The FDA was busy in January 2026, making a number of decisions on potential new therapeutic agents, including granting approvals, a designation, an acceptance, a clearance, and a priority review, as well as requesting a clinical study report.
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Marketed as Fayuvi, the 1-time AAV9 gene therapy showed sustained cerebrospinal fluid heparan sulfate drops and developmental gains among pediatric patients with mucopolysaccharidosis type IIIA in prior studies.
Microstructure Imaging has announced that the FDA cleared its MICSI-PET, an MR-guided PET enhancement platform with automated amyloid Centiloid and tau quantification.
FDA approval of apitegromab introduces a muscle-targeting approach to SMA treatment, with phase 3 data demonstrating motor-function benefit when added to existing SMN2-directed therapies.
The FDA granted priority review to satralizumab for MOGAD, positioning it to become the first approved treatment for the rare autoimmune disease.
Brian Lin, PhD, discussed the current evidence linking football participation with ALS, the questions that remain unanswered, and how emerging research may help clarify the association.
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