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CDC Backs Full Approval of Moderna COVID Vaccine
drugs.com
February 04, 2022
The U.S. Centers for Disease Control and Prevention on Friday gave its full approval to Moderna's COVID-19 vaccine for use in people 18 and older.
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AstraZeneca welcomes US government’s announcement to purchase additional 500,000 doses of Evusheld
ExpressPharma
January 14, 2022
Evusheld has Emergency Use Authorisation (EUA) for pre-exposure prophylaxis (prevention) of COVID-19.
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FDA expands EUA of Pfizer-BioNTech’s Covid-19 booster shot to adolescents
Pharmaceutical-Technology
January 05, 2022
The US Food and Drug Administration (FDA) has granted an expanded emergency use authorization (EUA) for the Pfizer and BioNTech’s Covid-19 vaccine’s booster dose to adolescents aged 12 years and above.
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Novavax submits final data to US FDA as prerequisite to EUA application request for COVID-19 vaccine
ExpressPharma
January 04, 2022
Novavax, Inc recently announced that it has completed submission of the final data package, including the complete chemistry, manufacturing and controls module...
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Novavax files Covid-19 vaccine data with FDA ahead of EUA application
Pharmaceutical-Technology
January 04, 2022
Novavax has submitted the final data package with the US Food and Drug Administration (FDA) to satisfy the requirements for seeking emergency use authorization (EUA) for its Covid-19 vaccine with Matrix-M adjuvant, NVX-CoV2373.
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India grants EUA to Bharat Biotech’s Covid-19 vaccine for use in children
Pharmaceutical-Technology
December 28, 2021
The Drug Controller General of India (DGCI) has granted Emergency Use Authorization (EUA) to Bharat Biotech’s Covid-19 vaccine, Covaxin, for use in children aged 12 to 18 years.
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US FDA grants EUA to AstraZeneca’s Evusheld in US for pre-exposure prophylaxis of COVID-19
expresspharma
December 10, 2021
Phase-III data showed at least six months of protection with one dose in high-risk participant population
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FDA grants EUA to AstraZeneca’s antibody therapy for Covid-19 prevention
Pharmaceutical-Technology
December 10, 2021
The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for AstraZeneca’s antibody therapy Evusheld for the pre-exposure prophylaxis or to prevent Covid-19.
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United Biomedical seeks appeal after EUA denied
firstwordpharma
August 24, 2021
United Biomedical Asia has urged the government to give its COVID-19 vaccine candidate, UB-612, a second chance after its application for emergency use authorization (EUA) was denied last week, Taipei Times reported.
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Ortho Clinical Diagnostics Expands COVID-19 Test Offerings with Emergency Use Authorization of Total Nucleocapsid Antibody Test
americanpharmaceuticalreview
August 09, 2021
Ortho Clinical Diagnostics, one of the world's largest pure-play in vitro diagnostics companies, announced its qualitative COVID-19 Total N antibody test received US FDA emergency use authorization (EUA).