House committees kick off investigation into how Biogen's Aduhelm won approval
Two key House committees — on Oversight and Reform, and Energy and Commerce — have now officially opened their own investigation into the approval of Biogen’s new Alzheimer’s drug Aduhelm by asking the company for a variety of different internal and external documents and communications relating to assessments of the drug’s safety, efficacy, or clinical benefit.
The committees are specifically targeting the way in which the FDA used the accelerated approval pathway to sign off on Aduhelm, despite not questioning its panel of outside experts (three of whom have since resigned) on whether such an accelerated approval would be appropriate.
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