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Dr Reddy’s initiates process for EUA of Sputnik V
expresspharma
February 22, 2021
As part of the review process, Dr Reddy's will present the safety profile of the phase 2 study, and interim data of the phase 3 study, which is expected to complete by February 2, 2021.
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New COVID-19 Antibody Test Receives EUA
americanpharmaceuticalreview
February 09, 2021
Scientists at the University of Denver have tested a new antibody test for COVID-19 that can predict if a patient will experience mild versus more severe symptoms of the virus.
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Janssen seeks EUA for Covid-19 vaccine candidate from US FDA
pharmaceutical-technology
February 07, 2021
Johnson & Johnson (J&J) unit Janssen Biotech has submitted an application seeking emergency use authorisation (EUA) for its investigational single-dose Covid-19 vaccine candidate to the US Food and Drug Administration (FDA).
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AstraZeneca’s Covid-19 vaccine gets EUA in Philippines
pharmaceutical-technology
February 01, 2021
AstraZeneca has obtained emergency use authorisation (EUA) from the Philippines Food and Drug Administration (FDA) for its Covid-19 vaccine, granted following a detailed review by medical and regulatory experts in the country.
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SML Genetree Receives EUA for Ezplex SARS-CoV-2 G Real-Time PCR Kit
americanpharmaceuticalreview
January 22, 2021
SML Genetree has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the use of its Ezplex SARS-CoV-2 G Kit, a molecular diagnostic test for the qualitative detection of RNA from SARS-CoV-2 from ...
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Pakistan grants EUA to Sinopharm’s Covid-19 vaccine
pharmaceutical-technology
January 19, 2021
The Drug Regulatory Authority of Pakistan (DRAP) has granted emergency use authorisation (EUA) to China National Pharmaceutical Group’s (Sinopharm) Covid-19 vaccine.
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Anvisa sends back request for EUA of Sputnik V vaccine
expresspharma
January 18, 2021
Anvisa said that Uniao Quimica, the pharma firm applying for EUA of Sputnik V vaccine, failed to provide adequate assurances on its Phase III clinical trials and issues related to the manufacture of the vaccine.
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AstraZeneca applies for emergency use for vaccine in Philippines
expresspharma
January 07, 2021
AstraZeneca has applied to health regulators for emergency use authorisation (EUA) of its COVID-19 vaccine in the Philppines, the food and drugs agency chief said on Wednesday.
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SEC recommends EUA for Covaxin from Bharat Biotech
expresspharma
January 04, 2021
The expert panel deliberated on Bharat Biotech’s EUA application after it submitted additional data, facts and analysis after Friday's review meeting.
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US FDA gives EUA to Moderna’s mRNA vaccine against COVID-19
expresspharma
December 21, 2020
Total of 200 million doses ordered by the US government to date, approximately 20 million doses will be delivered by the end of December 2020.