Biogen announces FDA’s 3 month extension of review period for the new drug application for tofersen

Biogen

17 October 2022 - The new Prescription Drug User Fee Act action date set by the FDA is 25 April 2023.

Biogen today announced that the US FDA has extended the review period of the new drug application for tofersen by three months.

Read Biogen press release

Michael Wonder

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Michael Wonder

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US , Timelines , Dossier , Gene therapy