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FDA issues emergency use authorisation for COVID-19 convalescent plasma europeanpharmaceuticalreview
August 26, 2020
The emergency use authorisation (EUA) allows the distribution and administration of COVID-19 convalescent plasma to hospitalised patients in the US.
FDA Issues EUA to Yale School of Public Health for SalivaDirect COVID-19 Test americanpharmaceuticalreview
August 20, 2020
The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection
FDA Authorizes Test for People without Known, Suspected COVID-19 Infection americanpharmaceuticalreview
July 31, 2020
The U.S. Food and Drug Administration (FDA) reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use ...
Luminex Files EUA for Expanded NxTAG Respiratory Panel Test Including SARS-CoV-2 americanpharmaceuticalreview
July 29, 2020
Luminex has submitted an EUA request to the U.S. Food and Drug Administration (FDA) for a new expanded version of its NxTAG® Respiratory Pathogen Panel (RPP) to include the SARS-CoV-2 virus for high-throughput COVID-19 testing.
Virality Diagnostics Antibody Test Wins FDA EUA americanpharmaceuticalreview
July 03, 2020
The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for a rapid COVID-19 antibody test distributed by Virality Diagnostics, manufactured by Biohit (Hefei).
US FDA revokes EUA for chloroquine and hydroxychloroquine expresspharma
June 17, 2020
The known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorised use, said the drug regulator.
FDA revokes authorisation for anti-malarials to treat Covid-19 pharmaceutical-technology
June 16, 2020
The US Food and Drug Administration (FDA) has revoked the emergency use authorisation (EUA) for anti-malarials, chloroquine phosphate and hydroxychloroquine sulfate, to treat some hospitalised Covid-19 patients.
US FDA seeks fast review of COVID-19 products: Commissioner Stephen Hahn expresspharma
June 12, 2020
Since the onset of the COVID-19 pandemic earlier this year, the FDA has issued a series of temporary emergency approvals ranging from diagnostic tests to treatments such as Gilead Sciences’ antiviral drug remdesivir.
FDA Provides Promised Transparency for Antibody Tests americanpharmaceuticalreview
May 28, 2020
The U.S. Food and Drug Administration (FDA) posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.
FDA Authorizes First COVID-19 Diagnostic Test Using At-Home Collection of Saliva Specimens americanpharmaceuticalreview
May 14, 2020
The U.S. Food and Drug Administration (FDA) has authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing.

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