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In March, experts who advise the FDA questioned the efficacy of an experimental new drug for ALS. In September, they voted to approve it anyway.
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Eighty-six-year-old Frank Jones volunteers at LovExtension in Tavares, a nonprofit that helps homebound seniors. We met there to talk about over-the-counter hearing aids. LovExtension President Linda Krupski and her sister
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Gov. Ron DeSantis’ administration has filed a lawsuit alleging that the U.S. Food and Drug Administration has not complied with a public-records request about the state’s proposed program to import cheaper prescription drugs from Canada.
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The two-dose vaccine uses a protein-based technology, unlike the mRNA approach used in vaccines made by Pfizer and Moderna. CDC approval is still needed for ages 12-17.
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Pfizer has submitted data on its bivalent COVID-19 booster shot that specifically targets the latest omicron subvariants. If authorized, the company says the shots could be ready as soon as September.
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The fruit-flavored gummies from Florida manufacturer VPR Brands could cause nicotine poisoning or even death if eaten by small children, the agency says.
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Some scientists are alarmed that the agency plans to evaluate the next generation of boosters by reviewing mouse studies alone. Others say there's no time to waste waiting for human trials.
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Previously, the FDA had advised taking two rapid antigen tests over two or three days to rule out infection. But the agency says new studies suggest that protocol can miss too many infections.
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The Biden administration is allowing the shot to be given between layers of skin — a method that only requires a fifth of the full dose — in order to increase vaccinations and slow the outbreak.
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An NPR investigation found stalled confirmatory trials and lax enforcement are plaguing the FDA's accelerated approval of drugs for urgent medical needs.
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FDA Commissioner Robert Califf says a nongovernmental research group will convene experts to deliver the evaluations within 60 business days.
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Birth control pills are available in the U.S. only with a prescription. Now a drugmaker is asking the FDA to approve a progestin-only contraceptive that would be available without one at pharmacies.