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How an Unproven Alzheimer's Drug Got Approved - The New York Times


How an Unproven Alzheimer’s Drug Got Approved
Though some of its own senior officials said there was little evidence of benefit for patients, the F.D.A. nonetheless greenlighted Biogen’s Aduhelm, or aducanumab.
The F.D.A. conducted an internal inquiry this year after allegations were made that the agency was collaborating too closely with Biogen, maker of the Alzheimer’s drug Aduhelm.Credit.Andrew Kelly/Reuters
Published July 19, 2021Updated July 20, 2021, 9:29 a.m. ET
Two months before the Food and Drug Administration’s deadline to decide whether to approve Biogen’s controversial Alzheimer’s drug, aducanumab, a council of senior agency officials resoundingly agreed that there wasn’t enough evidence it worked. ....

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Detailed text transcripts for TV channel - FOXNEWS - 20170304:20:51:00

The thing is, fda isn t taking full advantage of this legal authority. so what you need is an appointee who changes the culture at fda. paul: what else the problem at fda. the culture. the fda, its identity is glownld power and control, whether it s especially drug makers, fan pharmaceuticals, and and a square out of every dollar spent in the u.s. economy and they are not going to give you have that control. generic drugs are slow to come to market and more. you you have got to do the clinical trial to the get a drug approved. they are huge clinical trials. ....

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