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Index/Topics/Alzheimer's Drug Approval Pathway

Alzheimer's Drug Approval Pathway

The FDA's accelerated approval pathway for Alzheimer's drugs and its implications on patient access, safety, and costs.

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Jan 11, 2026

How do FDA accelerated approvals differ from traditional approvals for Alzheimer’s drugs?

The FDA’s accelerated approval pathway lets Alzheimer’s drugs reach patients earlier by allowing approval on surrogate endpoints “reasonably likely” to predict benefit, with mandatory post‑marketing (...

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