The FDA is requiring new labeling across all GLP-1 receptor agonists to warn of a potential increased risk of a rare, vision-threatening optic nerve condition.
News|Articles|July 6, 2026
FDA Action Update, June 2026: Acceptances, Clearances, and Alignments
Author(s)Isabella Ciccone, MPH
Catch up on any of the neurology headlines you may have missed in June 2026, compiled into 1 place by the NeurologyLive® team.
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The FDA was busy in June 2026, making a number of decisions on potential new therapeutic agents, including acceptances of new drug applications, reaching alignments, and scheduling an AdComm meeting.
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The FDA granted fast track designation to FRP-003, an investigational oral botanical drug candidate for Long COVID, ahead of a planned phase 2 trial evaluating fatigue in approximately 220 adults.
GV101 receives FDA fast track designation for the treatment of Friedreich ataxia, with a phase 2 trial planned to begin enrollment in late 2026.
The FDA has approved asundexian, the first factor XIa inhibitor indicated to reduce recurrent stroke after a noncardioembolic ischemic stroke or high-risk TIA, based on phase 3 OCEANIC-STROKE data.
Postmarketing reports of product-related insertional oncogenesis involving GLI1 have prompted an FDA investigation into malignancy risk with SMA gene therapy, onasemnogene abeparvovec.
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