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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