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FDA acting commissioner seeks watchdog review of Alzheimer's drug approval

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The acting commissioner of the Food and Drug Administration on Friday asked the Department of Health and Human Services’ inspector general to review the agency’s approval of a new Alzheimer’s drug.
July 9 (UPI) — The acting commissioner of the Food and Drug Administration on Friday asked the Department of Health and Human Services’ inspector general to review the agency’s approval of a new Alzheimer’s drug. The FDA gave the green light for a new drug marketed under the brand name Aduhelm in June. Manufactured by drugmaker Biogen, it’s the first to be approved for the debilitating form of dementia since 2003. But some experts — including the FDA’s own Peripheral and Central Nervous System Drugs Advisory Committee, which rejected the drug last November — argued that there is insufficient evidence that it helps patients with the disease.

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