1. Pink Sheet

FDA’s Mismanaged Aduhelm Review: What Went Wrong

 
• By Michael McCaughan

Two House committees have launched investigations into the US FDA approval of Biogen/Eisai’s Aduhelm for Alzheimer’s, assuring that headlines questioning the effectiveness of the therapy will continue. It didn’t have to be this way.

sad face on egg (Alamy)
FDA may have egg on its face after its handling of the Aduhelm review and approval. • Source: Alamy

The unfortunate reality for the US Food & Drug Administration is that what should have been a landmark approval of a first-of-its-kind disease-modifying agent for Alzheimer’s disease will now be a case study in how not to do an important product review.

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