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276 articles found
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FDA Roundup: February 25, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Feb. 24, the FDA issued an update on our continuing efforts to understand and reduce... -
FDA Roundup: February 22, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA posted a new resource, At-Home COVID-19 Diagnostic Tests, that provides a...
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FDA Roundup: February 18, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA is announcing that it has found an additional four lots of AstraZeneca CO...
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FDA Roundup: February 11, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Feb. 11, the U.S. Food and Drug Administration (FDA) opened the application portal fo...
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Coronavirus (COVID-19) Update: FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 that Retains Activity Against Omicron VariantToday, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant....
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Coronavirus (COVID-19) Update: FDA Postpones Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of AgeThe U.S. Food and Drug Administration has been notified by Pfizer that new data have recently emerged regarding its emergency use authorization request for the use of the Pfizer-BioNTech COVID-19 Vacc...
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FDA Roundup: February 4, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Feb. 3, the FDA issued a revised draft guidance for industry, “Assessment of Pressor...
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FDA Roundup: February 1, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Jan. 31, the FDA released a new video that provides an overview of the 2021 Food Alle...
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Coronavirus (COVID-19) Update: FDA Takes Key Action by Approving Second COVID-19 VaccineToday, the U.S. Food and Drug Administration approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the p...
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FDA Roundup: January 28, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:As part of the FDA’s efforts to help ensure Americans have access to compounded medicine...