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- FDA issues warning letters to 25 telehealth firms over misleading compounded GLP-1 marketingThe U.S. Food and Drug Administration has sent warning letters to 25 telehealth companies. The letters cite concerns about how the firms promote compounded GLP-1 drugs used for weight loss. The ag…
- UniQure plans to file Huntington’s disease gene therapy with FDA after leadership shift eases data requirementsUniQure, a Dutch biotech, announced it will seek FDA approval for its gene therapy targeting Huntington’s disease later this summer. The company said FDA staff indicated that three years of data f…