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Product Development

Biogen’s remaining options to bolster aducanumab’s case as PDUFA is extended

FDA wants more data, pushes back PDUFA date for Alzheimer’s therapy

FDA requests additional information and pushes back PDUFA date for Alzheimer’s candidate.

Jan 30, 2021 | 2:51 AM GMT

It’s unclear whether FDA is calling for more data from Biogen because it is looking for a rationale to approve aducanumab against the recommendation of its advisers, or whether it’s primarily stalling for time, avoiding the controversy until a new FDA commissioner is chosen.

Investors viewed Friday’s news that the agency had pushed back

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