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FDA Pushes Back Review of Neurizon’s ALS Drug NUZ-001 to October
10:11am on Friday 15th of August, 2025 AEST
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Biotechnology
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FDA Pushes Back Review of Neurizon’s ALS Drug NUZ-001 to October
10:11am on Friday 15th of August, 2025 AEST
Key Points
FDA extends review timeline for NUZ-001 IND response to October 3, 2025
Delay attributed to FDA restructuring and staffing shortages, not submission quality
Similar delays affecting other ALS drug programs reported
Neurizon actively engaging U.S. experts and advocacy groups to expedite review
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