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The FDA approved donanemab, which will be sold under the brand name Kisunla. The new drug helps slow decline in Alzheimer's patients with mild cognitive impairment.
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The story of MitraClip, a device Dr. Oz helped invent to treat faulty heart valves, is a cautionary tale about the science, business and regulation of medical technology.
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A flood of litigation — with plaintiffs like small businesses, drugmakers, and hospitals challenging regulations — could leave the country with a patchwork of disparate health regulations.
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The decision lends credibility to vaping companies’ claim that their products can help blunt the toll of smoking. Meantime, parents and anti-tobacco groups say the FDA has again “failed American families.”
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The high court threw out a challenge to the FDA's rules on the abortion drug. A recently enacted Florida law permits use of the pill up to six weeks of gestation, but the medication must be taken in front of a doctor.
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The FDA will make the final decision on approval later this year. If the agency agrees with advisers, donanemab would only be the second drug approved to slow cognitive decline due to Alzheimer’s.
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Advisers ultimately said sticking with JN.1 rather than its offshoots promises to offer a better chance at cross-protection. The FDA will decide the final recipe soon.
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A panel of outside experts voted against the potential use of MDMA for treating PTSD, citing that available evidence fails to show that the psychedelic is effective or that benefits outweigh risks.
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FDA scientists said patients who received MDMA and talk therapy showed “rapid, clinically meaningful, durable improvements in PTSD symptoms.” But they also called the research “challenging to interpret.”
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Mounting evidence suggests psychoactive drugs including LSD, ketamine, mushrooms and MDMA can be powerful treatments for severe depression and PTSD. But not everyone is convinced.