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FDA advisers support conditional clearance of Biogen’s ALS drug

March 22, 2023


The Food and Drug Administration may have an easier time deciding how to approach a closely watched medicine for ALS it is reviewing, after a group of agency advisers appeared to support a conditional approval during a meeting Wednesday.

The advisers voted 9-0 that the drug’s effect on an important protein linked to nerve damage was “reasonably likely” to predict a clinical benefit — a conclusion that aligns with the FDA’s standards for granting an accelerated approval

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