Novavax
United States
829 articles with Novavax
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A day after Pfizer and partner BioNTech submitted an EUA request to the FDA for their booster shot targeting Omicron variants BA.4 and BA.5, the regulator appears close to approving it.
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U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for Adolescents Aged 12 Through 17
8/19/2022
Novavax, Inc. announced that the Novavax COVID-19 Vaccine, Adjuvanted has received expanded emergency use authorization from the U.S. Food and Drug Administration to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 caused by severe acute respiratory syndrome coronavirus 2 in adolescents aged 12 through 17.
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The FDA is busy accepting drug applications, granting specialty designations and approving drugs for market. Here's a look at this week's FDA activity.
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Novavax Nuvaxovid™ COVID-19 Vaccine Granted Expanded Provisional Approval in New Zealand for Adolescents Aged 12 Through 17
8/18/2022
Novavax, Inc. (Nasdaq: NVAX), today announced that New Zealand's Medsafe has granted expanded provisional approval for Nuvaxovid™ (NVX-CoV2373).
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Novavax Nuvaxovid™ COVID-19 Vaccine Granted Expanded Provisional Approval in New Zealand as a First and Second Booster for Adults
8/17/2022
Nuvaxovid™ is New Zealand's first and only protein-based COVID-19 vaccine Nuvaxovid™ can now be used as a first or second booster dose for adults aged 18 and older vaccinated with any primary series vaccine.
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Novavax seeks EUA for COVID-19 Booster, a 100-year-old TB vaccine may protect against the disease and public health officials struggle with fall planning.
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Novavax Submits Application to the U.S. FDA for Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted as a Booster in Adults Aged 18 and Older
8/15/2022
Novavax, Inc. today announced that it submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its protein-based COVID-19 Vaccine, Adjuvanted.
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Novavax Nuvaxovid™ COVID-19 Vaccine Approved in South Korea for Use in Adolescents Aged 12 Through 17
8/12/2022
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that partner, SK bioscience, has received a Post Approval Change Application approval from the Korean Ministry of Food and Drug Safety (KMFDS) for Nuvaxovid™.
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Novavax to Participate in Fireside Chat at the SVB Securities Virtual Vaccine Forum
8/11/2022
Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced that it will participate in a fireside chat during the SVB Securities Virtual Vaccine Forum.
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Novavax released its second quarter financial results, showing a dramatic adjustment in its sales outlook, while BioNTech prepares to launch two variant-adopted bivalent shots.
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Novavax Reports Second Quarter 2022 Financial Results and Operational Highlights
8/8/2022
Novavax, Inc. (NASDAQ: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced its financial results and operational highlights for the second quarter ended June 30, 2022.
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With Monkeypox, COVID-19, Long COVID symptoms and persistent diseases like cancer and Alzheimer's, the world is dealing with a lot right now. Here's a look at the latest in clinical trial news.
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Novavax Announces Initiation of Phase 2b/3 Hummingbird™ Global Clinical Trial for the Novavax COVID-19 Vaccine in Children Aged Six Months Through 11 Years
8/4/2022
Novavax, Inc. today announced the initiation of its Phase 2b /3 Hummingbird™ global clinical trial.
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Novavax to Host Conference Call to Discuss Second Quarter 2022 Financial Results and Operational Highlights on August 8, 2022
8/1/2022
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced it will report its second quarter 2022 financial results and operational highlights on Monday, August 8, 2022, following the close of U.S. financial markets.
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Novavax Nuvaxovid™ COVID-19 Vaccine Granted Provisional Registration in Australia for Use in Adolescents Aged 12 Through 17
7/26/2022
Nuvaxovid™ is the first protein-based COVID-19 vaccine available for use in adolescents aged 12 through 17 in Australia.
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Novavax Announces Expanded Approval of Nuvaxovid™ COVID-19 Vaccine for Adolescents Aged 12 through 17 in Japan
7/26/2022
Nuvaxovid™ is the first protein-based COVID-19 vaccine approved for use in adolescents in Japan.
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COVID-19 Update: BA.4 and BA.5 Dominate, Long COVID Effects Continue, CDC Considers Novavax
7/19/2022
As the BA.4/BA.5 Omicron subvariants spread, researchers continue to develop COVID-19 therapies and approaches for preventing or treating the disease. For that and more, continue reading. -
U.S. CDC Advisory Committee Unanimously Recommends Novavax COVID-19 Vaccine, Adjuvanted as a Primary Series for Individuals Aged 18 and Older
7/19/2022
Recommendation follows U.S. FDA Emergency Use Authorization for the Novavax COVID-19 Vaccine, Adjuvanted as a two-dose primary series.
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Novavax Announces Expanded Agreement with SK bioscience to Manufacture COVID-19 Vaccine Containing Omicron Variant and Manufacture the Novavax COVID-19 Vaccine in Prefilled Syringes
7/19/2022
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, has signed agreements with its partner, SK bioscience, for the manufacturing and supply of a version of the Novavax COVID-19 vaccine.
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The FDA granted Novavax’s COVID-19 vaccine Emergency Use Authorization after a lengthy and obstacle-riddled journey. It is authorized as a two-dose primary series for adults 18 years and older.