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117 articles found
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Coronavirus (COVID-19) Update: March 2, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:The agency has updated its FDA COVID-19 Response At-A-Glance S... -
Coronavirus (COVID-19) Update: February 23, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:Yesterday, the FDA issued guidances for medical product develo...
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Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus VariantsToday, the U.S. Food and Drug Administration issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potent...
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Coronavirus (COVID-19) Update: February 16, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:As part of the FDA’s effort to protect consumers, the agency i...
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Coronavirus (COVID-19) Update: February 12, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:This week, the FDA posted the webpage, COVID-19 Vaccine Safety...
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FDA Approves Drug to Reduce Bone Marrow Suppression Caused by ChemotherapyToday, the U.S. Food and Drug Administration approved Cosela (trilaciclib) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving...
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Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults...
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Coronavirus (COVID-19) Update: February 5, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:The FDA has scheduled a meeting of its Vaccines and Related Bi...
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Coronavirus (COVID-19) Update: FDA Continues Important Work to Support Medical Product Development to Address New Virus VariantsAs the public health agency responsible for regulating medical products, we must ensure that health care providers have the most up-to-date diagnostics, treatments and vaccines in their toolbox to fig...
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Coronavirus (COVID-19) Update: January 29, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:This week, the FDA added a new frequently asked question (FAQ)...