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117 articles found
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Coronavirus (COVID-19) Update: May 28, 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, FDA released the Medical Countermeasures Initiative... -
Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 i...
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Coronavirus (COVID-19) Update: May 21, 2021The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:The FDA issued a reminder to health care providers to give clear, step-by-step ins...
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Coronavirus (COVID-19) Update: May 14, 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, on April 29,...
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Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of OperationsToday, the U.S. Food and Drug Administration issued a new report titled, “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the agency’s inspectional activities during the COVID-19 pandemi...
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Coronavirus (COVID-19) Update: May 4, 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 Center for Drug Evaluation and Research (CDER) continu...
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FDA Approves Treatment for Chronic Kidney DiseaseToday, the U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for h...
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Coronavirus (COVID-19) Update: April 27, 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: FDA Revokes Emergency Use Authorization for Monoclonal Antibody BamlanivimabToday, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be...
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Coronavirus (COVID-19) Update: April 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...