Tag: EUA

November 23, 2022

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Lucira Health’s COVID-19 & Flu Test for use in point-of-care settings. The nucleic acid amplification test (NAAT)/molecular test has been developed for the simultaneous rapid in […]

August 1, 2022

The US Food and Drug Administration (FDA) has re-authorised the emergency use authorization (EUA) for Meridian Bioscience’s Revogene SARS-CoV-2 molecular assay. The regulator initially granted EUA for the Covid-19 molecular diagnostic test last November. However, the company decided to delay […]

March 21, 2022

Last week, both Pfizer and Moderna applied for emergency use authorization (EUA) of additional booster doses — in essence, fourth doses — of their COVID-19 vaccines. The companies cite waning protection and believe fourth doses are needed. While Pfizer has […]

January 24, 2022

Applied DNA Sciences’ clinical laboratory subsidiary, Applied DNA Clinical Labs, has submitted a request seeking Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for two products. These products are the Linea 2.0 COVID-19 Assay and Linea […]

October 5, 2021

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Acon Laboratories’ Flowflex COVID-19 Antigen Home Test. Flowflex is an over the counter (OTC) antigen test, which uses nasal swab specimens from individuals suspected of active […]

June 21, 2021

Roche has received Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for the use of its cobas SARS-CoV-2 Nucleic acid test in point of care settings. Indicated for screening symptomatic as well as asymptomatic people, the […]

October 8, 2020

In a report published Oct. 8 in the New England Journal of Medicine, researchers confirmed the benefits of remdesivir for treating people hospitalized for COVID-19. Remdesivir, an antiviral drug, has emergency use authorization (EUA) from the U.S. Food and Drug […]