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J&J single-dose COVID-19 vaccine gets approval for EUA in India expresspharma
August 09, 2021
The single-shot vaccine in clinical trials proved to be 85 per cent effective in preventing COVID-19, and also showed protection against COVID-19 related hospitalisation and death.
FDA grants EUA for Regeneron’s antibody cocktail to prevent Covid-19 pharmaceutical-technology
August 02, 2021
The US Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for Regeneron Pharmaceuticals’ investigational antibody cocktail, REGEN-COV (casirivimab and imdevimab) to prevent Covid-19.
Ocugen to apply for full US FDA approval of Covaxin, not for EUA expresspharma
June 15, 2021
Ocugen said the decision was based on a recommendation from the US FDA, which also requested more information and data for full approval.
FDA revokes emergency use authorization for monoclonal antibody Bamlanivimab worldpharmanews
April 19, 2021
The U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in ...
GetMyDNA Receives EUA for COVID-19 Test Home Collection Kit for DTC Purchase americanpharmaceuticalreview
March 19, 2021
The U.S. Food and Drug Administration (FDA) issued emergency use authorization (EUA) to launch the GetMyDNA COVID-19 Test Home Collection Kit DTC, which is now available for broad use for both symptomatic and asymptomatic individuals with no ...
Covaxin granted restricted EUA expresspharma
March 12, 2021
Bharat Biotech’s indigenously developed Covaxin is out of the “clinical trial mode” and it has now been granted the restricted emergency use authorisation.
EU regulator advises caution on EUA for Sputnik COVID-19 vaccine expresspharma
March 09, 2021
Sputnik V has already been approved or is being assessed for approval in three EU member states - Hungary, Slovakia and the Czech Republic.
FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine americanpharmaceuticalreview
March 02, 2021
The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
AstraZeneca expects EUA in US for COVID-19 vaccine in April expresspharma
February 25, 2021
The company expects to be able to deliver 50 million doses of the vaccine by the end of April.
GenScript Receives EUA for Use of cPass SARS-CoV-2 Neutralization Antibody Test americanpharmaceuticalreview
February 24, 2021
GenScript has received Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) for use of the cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit in convalescent plasma ...

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