The FDA wants to pull its approval of a drug. It’s not so easy.

🇺🇸 Ars Technica (US) —

AI Summary

The FDA is seeking to withdraw approval for Tavneos, saying the drug was approved based on manipulated study data. The dispute raises questions about regulatory oversight and whether patients should retain access while the process is considered.

The regulator says Tavneos was approved on the basis of manipulated study data. Should patients still have access to it?

Health FDA Tavneos drug approval clinical study data manipulation patient access

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