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ADUHELM: The First FDA Approved Therapy for Alzheimer’s Disease Since 2003 Lin Zhang
July 20, 2021
Aducanumab, known as ADUHELM, was co-developed by Biogen and Eisai and newly approved by the United States Food and Drug Administration (FDA) on June 7, 2021 (BLA 761178) under the provisions of accelerated approval regulations (21 CFR 601.41).
Pharmaceutical Companies Back to the Blue Ocean of AD in the Wake of Aduhelm's Approval PharmaSources/Yefenghong
July 20, 2021
On June 8, the FDA issued an accelerated approval to Biogen/Eisai's powdered protein antibody Aduhelm (generic name aducanumab) for the treatment of Alzheimer's disease (AD).
Medicare May Rethink Premium Hike for Pricey Alzheimer Drug drugs
January 10, 2022
Medicare has been told to reassess a significant premium increase it had announced that largely stemmed from the expensive new Alzheimer disease drug Aduhelm.
Former FDA adviser calls for wider probe into Biogen Alzheimer’s drug approval expresspharma
July 22, 2021
A federal probe of the US Food and Drug Administration’s approval of a controversial new Alzheimer’s disease drug should look into why that decision was made without clear evidence of patient benefit, a former adviser to the agency said 20th.
Two Major Health Systems Will Not Administer Controversial Aduhelm drugs
July 16, 2021
Two major U.S. health systems say they will not administer Aduhelm, the controversial new drug for treating Alzheimer disease.
Medicare Mulls Coverage for Controversial Drug for Alzheimer Disease drugs
July 14, 2021
Medicare launched a formal process on Monday that will determine whether the agency will cover Aduhelm, the newly approved Alzheimer disease drug with a high price tag and unproven benefits that have prompted widespread controversy.
New Prescribing Instructions Tighten Use of Controversial Alzheimer's Drug drugs
July 09, 2021
The U.S. Food and Drug Administration on Thursday issued new prescribing rules for the controversial Alzheimer's medication Aduhelm that will likely limit its use.
New Rx Instructions Tighten Use of Controversial Alzheimer Disease Drug drugs
July 09, 2021
The U.S. Food and Drug Administration on Thursday issued new prescribing rules for the controversial Alzheimer disease medication Aduhelm that will likely limit its use.
Tipping the scales - Aduhelm’s hefty price under the spotlight cphi-online
July 07, 2021
Biogen’s Alzheimer’s drug Aduhelm has recently secured FDA approval to much fanfare.
House Committees to Investigate New Alzheimer Disease Drug Approval drugs
July 02, 2021
The U.S. Food and Drug Administration's controversial approval of a new drug for Alzheimer disease, along with its high price, is now being investigated by two House committees.

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