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An insider's perspective on FDA approval of aducanumab

INTRODUCTION: Aducanumab was approved in 2021 by the US Food and Drug Administration (FDA) under the accelerated approval pathway. Since then, there have been many misconceptions about the approval decision despite multiple publications from the FDA to explain the rationale. METHODS: Even though the...

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Detalles Bibliográficos
Autor principal: Wang, Yaning
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10193636/
https://www.ncbi.nlm.nih.gov/pubmed/37215506
http://dx.doi.org/10.1002/trc2.12382