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117 articles found
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Coronavirus (COVID-19) Update: September 17, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On Sept. 17, the FDA issued a Letter to Health Care Providers... -
Coronavirus (COVID-19) Update: September 10, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:Today, the FDA posted a statement titled “FDA Will Follow The...
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Coronavirus (COVID-19) Update: August 31, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On August 27, the FDA made changes to the authorized use of th...
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Coronavirus (COVID-19) Update: June 29, 2021The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:The FDA has sent to Congress its Report on Drug Shortages for Calendar Year 2020,...
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Coronavirus (COVID-19) Update: June 22, 2021The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:FDA issued a Drug Safety Communication for hand sanitizers, warning that symptoms...
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FDA Approves a Nasal Antihistamine for Nonprescription UseThe U.S. Food and Drug Administration today approved a nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription switch. The FDA approved Astepro (...
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Coronavirus (COVID-19) Update: June 8, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:The White House, the U.S. Department of Health and Human Servi...
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FDA Grants Accelerated Approval for Alzheimer’s DrugToday, the U.S. Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the acce...
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FDA Approves First Treatment for Patients with Plasminogen Deficiency, a Rare Genetic DisorderToday, the U.S. Food and Drug Administration approved Ryplazim (plasminogen, human-tvmh) for the treatment of patients with plasminogen deficiency type 1, also referred to as hypoplasminogenemia, a di...
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FDA Approves New Drug Treatment for Chronic Weight Management, First Since 2014Today, the U.S. Food and Drug Administration approved Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in adults with obesity or overweight with at least one weight-re...