The FDA Wants to Pull Its Approval of a Drug. It’s Not So Easy.
· undark.org · popularity 21/100 · 0 similar stories today · Public Health & Epidemiology (Health & Life Sciences)
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Summary
In 2021, the FDA was on the fence about whether to approve a new treatment for a rare form of vasculitis. After an advisory committee narrowly recommended approval, the agency greenlit the drug, Tavneos, and it started making its way into clinics. After uncovering evidence of what it says is data manipulation in the original trial, the agency wants to rescind the approval. But it's not so easy.
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