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Controversial Alzheimer’s Drug Takes Step Toward FDA Approval

Aug. 7, 2020, 12:38 PM

Biogen Inc.’s experimental Alzheimer’s disease treatment aducanumab was granted priority review status by U.S. regulators, a move that could hasten the drug’s arrival on the market.

The company said in a statement Friday that the Food and Drug Administration had granted its application with an action date of March 7, though it said the agency could act earlier under an expedited review.

Shares of the Cambridge, Massachusetts-based biotechnology company climbed by 12% in premarket trading on Friday.

The priority review had been sought by Biogen and its Japan-based partner Eisai Co. when the companies submitted their application for approval ...

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