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Tag: Alzheimer’s

FDA Head Asks for Investigation Into Alzheimer Disease Drug Approval

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Request follows reports that Biogen and the FDA held off-the-books meetings before the drug's approval that may have violated FDA protocol

New Rx Instructions Tighten Use of Controversial Alzheimer Disease Drug

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Major changes to prescribing instructions are rare, especially so soon after approval; change could curb the drug's use

Changes in Movement May Indicate Preclinical Alzheimer Disease

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Changes in daytime fractal motor activity regulation may occur in women before cognitive symptoms of Alzheimer disease

House Committees to Investigate New Alzheimer Disease Drug Approval

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FDA approved Aduhelm earlier this month, despite advisory committee's conclusion that there was not enough evidence to support its effectiveness

Lilly to Seek FDA Approval for New Drug for Alzheimer Disease

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Donanemab has already received a 'breakthrough therapy' designation from the FDA

Three FDA Advisers Quit Over Agency Approval of Aduhelm

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Several experts have said the available evidence about Aduhelm raises significant doubts about its effectiveness

FDA Approves Aduhelm for Alzheimer Disease

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Agency says it has granted approval on the condition that drug maker Biogen conduct a new clinical trial

Donanemab Studied in Early Symptomatic Alzheimer Disease

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Slightly less cognitive and functional decline seen with donanemab versus placebo at 76 weeks in phase 2 trial

AAN: Prior Psych Diagnosis Tied to Younger Age of Alzheimer Onset

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Findings based on data from retrospective chart review of patients at tertiary specialty memory care center

Many Non-Whites Experience Discrimination in Alzheimer Disease Care

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Overall, 36, 19, and 18 percent of Black, Hispanic, Asian Americans, respectively, believe discrimination is barrier to receiving care