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FDA Approves Controversial New Alzheimer’s Drug

Aduhelm received “accelerated approval” despite differing perspectives from the expert community.

A recent CNN Health article discussed the FDA’s approval of Biogen’s experimental drug for early phases of Alzheimer’s disease. The drug, aducanumab, was developed to treat patients with mild cognitive impairment and slow the progression of the neurodegenerative disease, and not just the symptoms. However, an FDA advisory committee determined last year that there wasn’t enough support that the treatment is actually effective.

Medical Device Innovations Report
Cutting-edge packaging technologies are transforming the medical device sector in PMMI’s “Innovation in Medical Device” report, featuring advanced materials, smart solutions, and evolving regulations. Editors share insights from nearly 300 PACK EXPO booth visits—each product deemed new and truly innovative—alongside video demonstrations of the equipment and materials on display.
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Medical Device Innovations Report
FDA warning letters surge - is your team prepared?
New guide reveals expert strategies to prevent regulatory issues and respond effectively to FDA enforcement actions in pharmaceutical and medical device manufacturing.
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FDA warning letters surge - is your team prepared?