FDA approves once-daily oral tavapadon for Parkinson disease, a first-in-class D1/D5 partial agonist that improves motor function and ON time, with key safety warnings.
News|Articles|December 10, 2025
FDA Action Update, November 2025: Approvals, Clearance, and Boxed Warning
Author(s)Isabella Ciccone, MPH
Catch up on any of the neurology news headlines you may have missed in November 2025, compiled into 1 place by the NeurologyLive® team.
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The FDA was busy in November 2025, making a number of decisions on potential new therapeutic agents, including granting approvals and a clearance, issuing a complete response letter, adding a box warning, providing feedback, and reconsidering its stance on a submission.
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Early phase 1 findings showed that the PROTAC LRRK2 degrader ARV-102 was associated with improvements in saccadic hypometria and changes in CSF markers of endolysosomal function, neuroinflammation, synaptic integrity, and axonal guidance in participants with Parkinson disease.
Full results from the phase 2b LUMA showed that investigational BIIB122/DNL151 did not slow confirmed clinical worsening in early-stage Parkinson's disease compared with placebo.
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