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Home » FDA Advisory Committee Suggests Accelerated Approval for Biogen’s Tofersen
FDA Advisory Committee Suggests Accelerated Approval for Biogen’s Tofersen
Members of an FDA advisory committee agreed in a 5-3 vote yesterday that clinical data on Biogen’s tofersen — a first-in-class drug candidate for a rare type of amyotrophic lateral sclerosis (ALS) — didn’t support a full approval, but said it might pass muster for an Accelerated Approval.