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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 ...
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 ...
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]
In December 2021, the United States Food and Drug Administration (FDA) granted nirmatrelvir/ritonavir emergency use authorization (EUA) to treat COVID‑19. [13] [22] It was approved in the United Kingdom later that month, [23] and in the European Union and Canada in January 2022. [15] [24] [25] In May 2023, it was approved in the U.S. to treat ...
“It’s unlikely that we will ever get back to normal without a combination of one or more good vaccines and one or more good treatments,” says H. Dirk Sostman, MD, president of the Houston ...
It includes laboratory research on microorganisms and animals, filing for regulatory status, such as via the FDA, for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug.