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Results For "EUA"

105 News Found

DCGI grants EUA to Truenat for conducting Nipah virus tests
Digitisation | September 09, 2021

DCGI grants EUA to Truenat for conducting Nipah virus tests

Nipah virus (NiV) is an emerging zoonotic disease that causes severe disease in humans. Signs and symptoms range from asymptomatic to acute respiratory infection and fatal encephalitis


Zydus applies to the DCGI for EUA to launch ZyCoV-D
News | July 01, 2021

Zydus applies to the DCGI for EUA to launch ZyCoV-D

ZyCoV-D had already exhibited a robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials


DGCI grants Emergency Use Authorisation to Gennova mRNA Covid booster vaccine
News | June 21, 2023

DGCI grants Emergency Use Authorisation to Gennova mRNA Covid booster vaccine

The booster vaccine can be administered safely to individuals who have received two doses of either Covaxin or Covishield


Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine
Drug Approval | February 25, 2023

Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine

This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.


Hetero's COVID-19 oral drug gets WHO prequalification
News | December 27, 2022

Hetero's COVID-19 oral drug gets WHO prequalification

WHO made a strong recommendation for nirmatrelvir and ritonavir for mild and moderate COVID-19 patients at highest risk of hospital admission


Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age
Drug Approval | September 27, 2022

Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age

The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses


USFDA grants emergency use authorization for Novavax COVID-19 vaccine
Drug Approval | August 22, 2022

USFDA grants emergency use authorization for Novavax COVID-19 vaccine

Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.


U.S. FDA grants emergency use authorization for Novavax COVID-19 vaccine
Drug Approval | July 15, 2022

U.S. FDA grants emergency use authorization for Novavax COVID-19 vaccine

Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.


India’s first mRNA vaccine from Gennova gets DCGI approval
Drug Approval | June 30, 2022

India’s first mRNA vaccine from Gennova gets DCGI approval

It is a two dose vaccine to be administered intramuscularly at 28 days apart


Biolexis and Akston Biosciences announce encouraging results of thermostable 2nd Gen COVID-19 vaccine
News | June 24, 2022

Biolexis and Akston Biosciences announce encouraging results of thermostable 2nd Gen COVID-19 vaccine

An interim analysis of this data shows no significant safety issues and a 91% seroconversion rate at Day 56.