The new plasma-based diagnostic tool is intended to improve early detection of Alzheimer’s through a less invasive method. The U.S. Food and Drug Administration (FDA) has cleared the…
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FDA Schedules Panel Meeting on Alzheimer’s Drug
The June meeting was scheduled after expedited approval was denied. The Food and Drug Administration (FDA) announced this week that it has scheduled a meeting of the Peripheral…
Read MoreFDA Fully Approves Alzheimer’s Drug Leqembi
This traditional approval follows previously fast-tracked authorization. The Food and Drug Administration (FDA) has approved Leqembi for the treatment of Alzheimer’s disease. The FDA included a safety warning…
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Congress Issues Report on FDA’s Aduhelm Approval
House committees are concerned with the atypical protocol that was followed. Two House committees published a report at the end of the year highlighting the irregular means the…
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HHS Secretary Orders Alzheimer’s Drug Price be Reassessed
Response to Medicare’s announcement of Aduhelm price hike. Secretary of Health and Human Services Xavier Becerra ordered a reassessment of Medicare’s proposed pricing for Aduhelm on Monday. The…
Read MoreFDA Calls for Investigation into Alzheimer’s Drug
Probe comes after three members of the drug advisory board resigned in protest. On Friday, Food and Drug Administration Acting Commissioner Dr. Janet Woodcock called for an independent…
Read MoreFDA Accelerates Alzheimer Drug
Some “residual uncertainties” in test results acknowledged. This past week, the U.S. Food and Drug Administration approved Biogen’s new drug, Aduhelm, for treating Alzheimer’s disease, which showed in…
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NIH Invests in Advanced Research for Alzheimer’s
Entering into public-private partnership to expand therapies and interventions. The National Institutes of Health announce the launch of the next version of the program that expands scientific research…
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