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Lilly to Seek FDA Approval for New Drug for Alzheimer Disease drugs
June 28, 2021
Fresh on the heels of the U.S. Food and Drug Administration approval of the controversial Alzheimer disease drug Aduhelm, the maker of a second medicine that works in similar fashion said Thursday it hopes to apply for approval of its medication later .
Memos reveal internal FDA struggle over thorny Alzheimer's drug approval firstwordpharma
June 23, 2021
The FDA on Tuesday made public new documents laying bare a struggle within the agency ahead of its controversial decision on June 7 to grant accelerated approval to Biogen and Eisai's Alzheimer's drug Aduhelm (aducanumab) amid heated debate
Third member of FDA expert panel exits amid Alzheimer's drug flap firstwordpharma
June 11, 2021
The FDA's controversial decision to approve Biogen and Eisai's Alzheimer's disease treatment Aduhelm (aducanumab) has prompted a third member to resign from the advisory committee that had solidly voted down the drug during a consultation meeting.
FDA AdCom roster shrinks as two quit over Aduhelm approval firstwordpharma
June 10, 2021
Mayo Clinic neurologist David Knopman on Wednesday became the second member of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee (AdCom) to resign in protest at the agency's decision earlier this week to approve Biogen
Biogen gets US FDA accelerated approval for Aduhelm to treat Alzheimer’s expresspharma
June 09, 2021
It is the first new treatment approved for Alzheimer's since 2003 and is the first therapy that targets the fundamental pathophysiology of the disease.
First-of-its-kind Alzheimer’s drug gains US FDA approval cphi-online
June 09, 2021
Biogen and Eisai's Aduhelm approved using the accelerated approval pathway after clinical trials demonstrated it reduced amyloid beta plaques by up to 71%
FDA Grants Accelerated Approval for Alzheimer’s Drug fda.gov
June 09, 2021
Today, the U.S. Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans.

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