An 18-month congressional investigation found the FDA didn't follow its own guidance and inappropriately collaborated with drugmaker Biogen before the approval of a controversial Alzheimer's drug last year.
that target proteins believed to contribute to the development of Alzheimer's.
An outside advisory committee of experts recommended against approving the drug.
Biogen initially set Aduhelm’s price at an "unjustifiably high" $56,000 per year despite a lack of demonstrated clinical benefit, the anticipated financial impact on patients and the Medicare program, in order to maximize revenue and "make history.
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Congressional report: U.S. FDA broke own protocols in approving Biogen Alzheimer's drugThe U.S. Food and Drug Administration failed to adhere to its own guidance and internal practices during the approval process for Biogen's Alzheimer's drug Aduhelm, which was 'rife with irregularities,' a congressional report showed on Thursday.
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FDA Faulted for Working Improperly With Biogen Before Clearing Alzheimer’s DrugBreaking: The FDA inappropriately collaborated with Biogen before approving its Alzheimer's drug Aduhelm, a report by House Democrats found
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Sesame will join the major food allergens list on January 1, FDA says | CNNSesame will be included in the list of major food allergens and subject to food allergen regulatory requirements, starting January 1. Here's what will change.
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A common ingredient will join the major food allergens list on January 1, FDA saysStarting January 1, sesame will join the list of major food allergens defined by law, according to the US Food and Drug Administration.
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