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277 articles found
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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... -
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...
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FDA Roundup: January 21, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA announced two FY 2022 funding opportunities that could provide up to $800...
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FDA Roundup: January 14, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the Interagency Food Safety Analytics Collaboration — a collaboration between the...
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Coronavirus (COVID-19) Update: FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five MonthsToday, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccin...
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Coronavirus (COVID-19) Update: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 VaccineToday, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to:Expand the use of a single booster dose to include use in individ...
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Coronavirus (COVID-19) Update: December 28, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On Monday, the U.S. District Court for the District of New Jer...
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Coronavirus (COVID-19) Update: December 23, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On Wednesday, the FDA updated the SARS-CoV-2 Viral Mutatio...
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Coronavirus (COVID-19) Update: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain AdultsToday, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Merck’s molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with po...
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Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment...