Biogen and Eisai announce FDA's 3 month extension of review period for the biologics license application for aducanumab

Biogen

29 January 2021 - The new Prescription Drug User Fee Act action date set by the FDA is 7 June 2021

Biogen and Eisai today announced that the U.S. FDA has extended the review period by three months for the biologics license application for aducanumab, an investigational treatment for Alzheimer’s disease.

Read Biogen press release

Michael Wonder

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Michael Wonder

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Medicine , US , Timelines , Dossier