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A later congressional investigation described an unusually close collaboration between FDA staff and Biogen during the review.In 2022, an FDA panel rejected the ALS drug Relyvrio for weak data, then reversed course after ALS patients lobbied hard at a second meeting

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“Noninvasive Vagus Nerve Stimulation as Acute Therapy for Migraine: The Randomized PRESTO Study.” Neurology 91: e364–e373