Take 5 minutes to catch up on NeurologyLive®'s highlights from the week ending October 23, 2026.
News|Articles|August 3, 2026
FDA Action Update, July 2026: Approval, Acceptances, and Advisory Committee Vote
Author(s)Isabella Ciccone, MPH
Catch up on any of the neurology headlines you may have missed in July 2026, compiled into 1 place by the NeurologyLive® team.
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The FDA was busy in July 2026, making a number of decisions on potential new therapeutic agents, including a formulation approval, acceptances of new drug applications (NDAs), and voting at an advisory committee meeting.
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AL-S Pharma outlined the design of AP101-03, a planned phase 3 trial of AP-101 in sporadic and SOD1-associated ALS, at the 2026 NEALS Annual Meeting.
Sabirnetug failed to meet its primary endpoint in Acumen Pharmaceuticals' phase 2 ALTITUDE-AD trial for early Alzheimer disease, prompting the company to end development.
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Interim phase 1b/2a data showed all patients treated with high- or low-dose BB-301 for oculopharyngeal muscular dystrophy met formal response criteria.
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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.
Fast track status covers AV-1959R, an investigational amyloid-beta vaccine, for preventing Alzheimer disease in cognitively unimpaired adults with amyloid pathology.
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