FDA and Biogen discussed Aduhelm's accelerated approval as early as 2019 — report
Top FDA neuroscience official Billy Dunn has been a vocal advocate for Biogen and its Alzheimer’s drug Aduhelm throughout the entire review process all the way up to the drug’s divisive accelerated approval. That enthusiasm — which had drawn the ire of advocacy groups and the adcomm of outside experts — seems to stem from a series of meetings between the company and Dunn dating back as far as 2019, STAT reports, when the Cambridge, MA drugmaker launched a secret campaign dubbed Project Onyx to win approval for aducanumab.
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