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On 22 October 2019, Biogen announced that it would be restarting the FDA approval process for aducanumab stating that analysis of a larger dataset from its Phase 3 trials [33] [34] [35] showed that the drug reduced clinical decline in patients with early Alzheimer's disease when given at higher doses. [36]
In early 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to a new Alzheimer’s drug called Leqembi. (Biogen, a biotechnology company, and Eisai, a pharmaceutical ...
The U.S. Food and Drug Administration has approved Biogen's aducanumab, the first drug to target an underlying cause of Alzheimer's disease. The drug, to be sold under the brand Aduhelm, is the ...
After a lull of nearly 2 decades, the Food and Drug Administration (FDA) has approved some novel drugs for the treatment of Alzheimer’s disease since 2021.
LOS ANGELES (Reuters) -Eisai and Biogen's Leqembi won a coveted standard approval nod from the U.S. Food and Drug Administration on Thursday, the first Alzheimer's treatment to achieve that goal ...
However, an advisory panel for the FDA voted against approval of this drug. [95] On June 7, 2021, the FDA granted approval of Aducanumab for the treatment of Alzheimer's disease. Aducanumab was approved using the accelerated approval pathway, and Biogen will be required to conduct a post-approval clinical trial to verify clinical benefit for ...
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