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In a 17-4 vote, an expert committee concluded that the scientific evidence supports the authorization of the COVID-19 vaccine from Pfizer and BioNTech for emergency use during the pandemic.
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A Pfizer board member says the government declined to buy more doses beyond the initial 100 million already agreed upon. Demand from other countries could complicate future purchases.
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The Food and Drug Administration finds "no specific safety concerns" that would stand in the way of authorization of the vaccine for emergency use. Effectiveness is 95% after two doses.
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Operation Warp Speed is allocating the first batch of 6.4 million COVID vaccines to states, based on population. This circumvents a CDC advisory committee, which proposed allocation based on risk.
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The drug, which has been named Veklury, works by inhibiting a substance the coronavirus uses to make copies of itself. A large U.S. study found that the antiviral cut the recovery time by five days.
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The agency announced approval for the diagnostic method on Saturday. Cheaper and easier to administer than genetic tests for the virus, it could potentially expand to daily testing of millions.
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Most coronavirus antibody test-makers are choosing to skip FDA verification, says Raja Krishnamoorthi of the House Subcommittee on Economic and Consumer Policy.
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The Trump administration recently passed a law making it illegal to sell tobacco products, including e-cigarettes to anyone under 21. Health News…
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The U.S. Food and Drug Administration announced this week a new proposal to update safety standards for sunscreen ingredients and marketing.The updated…
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About 40 percent of the Food and Drug Administration employees will go on unpaid leave starting Wednesday. The remaining staffers will respond to emergencies and continue work funded by user fees.
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A second E. coli outbreak associated with romaine lettuce has public health officials warning against eating the leafy green vegetable.
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The maker of a permanent contraceptive implant subject to thousands of injury reports and repeated safety restrictions by regulators said Friday that it...