FDA de­lays Bio­gen's ALS drug re­view by three months, de­ci­sion to now come next April

At­tempt­ing to push for­ward an ALS drug de­spite a failed Phase III study, Bio­gen saw its FDA re­view date de­layed Mon­day.

The big biotech an­nounced that the agency pushed back its de­ci­sion dead­line by three months to April 25, 2023 for tofersen, an an­ti­sense drug de­signed to treat a ge­net­ic sub­set of ALS. Bio­gen had pre­vi­ous­ly re­ceived pri­or­i­ty re­view for the ap­pli­ca­tion, which will fall un­der the ac­cel­er­at­ed ap­proval path­way.

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