Take 5 minutes to catch up on NeurologyLive®'s highlights from the week ending October 23, 2026.
News|Articles|March 5, 2026
FDA Action Update, February 2026: Complete Response Letter, Expanded Indication, and Acceptance
Author(s)Isabella Ciccone, MPH
Catch up on any of the neurology headlines you may have missed in February 2026, compiled into 1 place by the NeurologyLive® team.
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The FDA was busy in February 2026, making a number of decisions on potential new therapeutic agents, including issuing a complete response letter (CRL), granting an expanded approval indication, accepting a new drug application (NDA), and granting a priority review.
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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.
Take 5 minutes to catch up on NeurologyLive®'s highlights from the week ending October 16, 2026.
Adults with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive now have a second self-administration option for the complement inhibitor zilucoplan.
Here's some of what is coming soon to NeurologyLive® this week.
Here's some of what is coming soon to NeurologyLive® this week.
Leonard Dragone, MD, PhD, Disease Area Leader at Johnson & Johnson, discusses how nipocalimab is being incorporated into generalized MG care, what long-term data show, and where J&J sees the therapy’s role evolving.
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