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FDA

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FDA Demands Placebo-Controlled Trial for UniQure’s Huntington’s Gene Therapy

A senior official publicly rejected UniQure’s external-control evidence to set expectations for randomized data.

FDA Warns 30 Telehealth Firms Over Misleading Ads for Compounded GLP-1 Weight-Loss Drugs

Chinese Weight-Loss Drug Suppliers Pivot to Generics as U.S. Crackdown Ends Copycat Boom