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An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a ...
Remdesivir is the first treatment for COVID‑19 to be approved by the US Food and Drug Administration (FDA). [63] The approval by the FDA does not include the entire population that had been authorized to use remdesivir under an Emergency Use Authorization (EUA) originally issued in May 2020. [ 63 ]
As of February 2021, in the United States, only remdesivir had FDA approval for certain COVID-19 patients, [67] and while early research had suggested a benefit in preventing death and shortening illness duration, this was not borne out by subsequent trials. [68] [needs update]
The Food and Drug Administration granted an emergency use authorization for high-risk patients 12 years and older on March 22. Individuals must also weigh 88 pounds to use the drug. Individuals ...
A study published in October 2020, screening those drugs approved by the US Food and Drug Administration (FDA) which target SARS-CoV-2 spike (S) protein proposed that the current unbalanced combination formula of lopinavir might in fact interfere with the ritonavir's blocking activity on the receptor binding domain-human angiotensin converting ...
The authorization for the therapy, made up of two monoclonal antibodies tixagevimab and cilgavimab, marks a significant step for AstraZeneca, whose widely used COVID-19 vaccine is yet to be ...
On 21 November 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate [COVID‑19] in people twelve years of age or older weighing at least 40 kilograms (88 lb) with positive results of direct SARS-CoV-2 viral ...
Sotrovimab, sold under the brand name Xevudy, is a human neutralizing monoclonal antibody with activity against severe acute respiratory syndrome coronavirus 2, known as SARS-CoV-2. [ 10 ] [ 12 ] [ 13 ] It was developed by GlaxoSmithKline and Vir Biotechnology, Inc. [ 12 ] [ 14 ] Sotrovimab is designed to attach to the spike protein of SARS-CoV-2.