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The FDA Wants to Pull Its Approval of a Drug. It’s Not So Easy.

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.

The FDA Wants to Pull Its Approval of a Drug. It’s Not So Easy.

We haven't written up this one. Undark has the full story — the link below goes straight to it.

Read the original at undark.org →

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