1. Revisiting FDA Approval of Aducanumab.
- Author
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Alexander, G. Caleb, Knopman, David S., Emerson, Scott S., Ovbiagele, Bruce, Kryscio, Richard J., Perlmutter, Joel S., and Kesselheim, Aaron S.
- Subjects
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MEDICAL research , *PHYSICIANS , *BIOMARKERS , *MEDICAL societies , *MILD cognitive impairment , *ADUCANUMAB , *DRUG approval , *THERAPEUTIC use of monoclonal antibodies , *ALZHEIMER'S disease , *TIME , *POLICY sciences , *PEPTIDES , *CHEMICAL inhibitors - Abstract
The article focuses on Revisiting the Food and Drug Administration (FDA) Approval of Aducanumab. Topics discussed include the Food and Drug Administration (FDA) granted accelerated approval to aducanumab (Aduhelm) for treatment of Alzheimer's disease; and the FDA made a late-stage decision to grant approval on the basis of aducanumab's ability to lower levels of beta-amyloid observable on positron-emission tomographic brain imaging.
- Published
- 2021
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