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Saturday, April 13, 2024 4:31:03 PM
You can argue about the approval of the Aduhelm drug against the advisory committee advice and that would be a legit argument. That also lead to investigations etc.
I can think of 3 controversial decisions in the last several decades.
The one you list where Biogen (a BP) had their drug conditionally approved.
The approval of Sarepta's (not a BP) Duchenes MD treatment for young boys
The approval of the "day after" plan B drug that was initially nixed by the political head of the FDA (who has never done so before AFAIK).
So, one political, one pro BP, one pro smaller company.
Out of thousands. While MHRA approved 8 new drugs last year that were not rubber stamps of EU approvals.
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