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FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Influenza and COVID-19 Viruses

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The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly...

FDA releases report to shed light on 2020 salmonella outbreak linked to red onions

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By Teddy Cambosa The Food and Drug Administration (FDA) in the United States has announced the publication of a new report on the comprehensive findings about the 2020 salmonella outbreak directly linked...

COVID-19 testing: BinaxNOW Ag card home test gets FDA authorization

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The U.S. Food and Drug Administration issued Wednesday a new emergency use authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test which is authorized for use by patients at home with a prescription. The...

COVID-19 OTC at-home test receives FDA nod

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By NewsDesk  @bactiman63 The U.S. Food and Drug Administration (FDA) today issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19....

COVID-19

COVID-19 vaccines: Moderna to file for FDA EUA

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By NewsDesk  @bactiman63 Massachusetts based biotechnology company, Moderna, announced today that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high...

COVID-19: FDA broadens EUA for remdesivir

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As part of its ongoing efforts to fight COVID-19, the U.S. Food and Drug Administration today broadened the scope of the existing emergency use authorization (EUA) for the drug Veklury (remdesivir) to...

COVID-19 antigen test receives EUA, Similar in design to some pregnancy tests

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Earlier this week, the U.S. Food and Drug Administration issued an emergency use authorization for the first antigen test where results can be read directly from the testing card, a similar design to...

COVID-19

COVID-19: FDA issues EUA for convalescent plasma as potential treatment

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The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) today for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the...

COVID-19

COVID-19 treatment: Gilead submits New Drug Application to FDA for Remdesivir

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Gilead Sciences, Inc. announced Monday that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Veklury® (remdesivir), an investigational antiviral for the...

COVID-19

FDA Issues EUA for OraRisk COVID-19 RT-PCR Test

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Access Genetics, LLC dba OralDNA® Labs announces that FDA has issued an Emergency Use Authorization for its OraRisk® COVID-19 RT-PCR test. This test is for qualitative detection of nucleic acid from...