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Results For "Novavax"

43 News Found

Novavax's Nuvaxovid receives full marketing authorization in the EU
News | July 10, 2023

Novavax's Nuvaxovid receives full marketing authorization in the EU

Marketing Authorization replaces conditional Marketing Authorization and is first for Novavax in the EU


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.


Novavax statement on EMA Nuvaxovid label update related to allergic reaction
News | July 15, 2022

Novavax statement on EMA Nuvaxovid label update related to allergic reaction

Novavax’ clinical development program reported no severe allergic reactions


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.


Novavax aims COVID vaccine on Omicron in Q4
Drug Approval | July 05, 2022

Novavax aims COVID vaccine on Omicron in Q4

The vaccine is under FDA review


Novavax initiates phase 3 trial of its COVID-19 omicron booster
Biotech | June 01, 2022

Novavax initiates phase 3 trial of its COVID-19 omicron booster

Trial will assess safety and antibody responses of NVX-CoV2515 to the Omicron variant of COVID-19


Novavax files for expanded conditional marketing authorisation for Nuvaxovid as a booster in Europe
News | May 21, 2022

Novavax files for expanded conditional marketing authorisation for Nuvaxovid as a booster in Europe

The European Commission granted CMA in December 2021 for use of Nuvaxovid in individuals aged 18 and over, and Novavax filed for expanded CMA for use in adolescents aged 12 through 17 in March 2022


Novavax submits variations to expand approval in Australia and New Zealand for adolescents
Biotech | May 08, 2022

Novavax submits variations to expand approval in Australia and New Zealand for adolescents

If granted, Nuvaxovid would be the first protein-based Covid-19 vaccine option for adolescents in Australia and New Zealand


Novavax initiates Covid-19 booster study in adolescents in Phase 3 trial
Biotech | April 23, 2022

Novavax initiates Covid-19 booster study in adolescents in Phase 3 trial

Continuation of pediatric expansion in adolescents of PREVENT-19 Phase 3 trial will evaluate safety and immunogenicity of a booster dose


Switzerland grants conditional marketing authorisation for Novavax Covid-19 vaccine
Biotech | April 13, 2022

Switzerland grants conditional marketing authorisation for Novavax Covid-19 vaccine

Nuvaxovid is the first protein-based Covid-19 vaccine authorized for use in Switzerland