Take 5 minutes to catch up on NeurologyLive®'s highlights from the week ending October 16, 2026.
News|Articles|August 12, 2025
FDA Action Update, July 2025: Approval, Label Update, Complete Response Letter
Author(s)Isabella Ciccone, MPH
Catch up on any of the neurology news headlines you may have missed over the course of July 2025, compiled all into 1 place by the NeurologyLive® team.
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The FDA was busy in July 2025, making a number of decisions on potential new therapeutic agents, including granting an approval, a clearance, a label update, and a priority review, issuing a complete response letter, and suspending a distribution.
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Take 5 minutes to catch up on NeurologyLive®'s highlights from the week ending October 9, 2026.
The FDA set a first quarter 2027 goal date for troriluzole in spinocerebellar ataxia and plans an advisory committee after a 2025 complete response letter.
Clene has filed an NDA seeking accelerated approval of CNM-Au8 for ALS, following 2 missed primary trial endpoints and years of evolving FDA guidance.
Here's some of what is coming soon to NeurologyLive® this week.
Adults with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive now have a second self-administration option for the complement inhibitor zilucoplan.
The designation follows phase 2 ClearMEMory data in which the oral NMDA receptor antagonist improved objective cognitive performance over placebo at 12 weeks.
Here's some of what is coming soon to NeurologyLive® this week.
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