Novavax
715 articles with Novavax
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Australia Therapeutic Goods Administration (TGA) Grants Provisional Registration for Novavax COVID-19 Vaccine
1/19/2022
Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced that Australia's Therapeutic Goods Administration has granted approval for provisional registration of NVX-CoV2373, Novavax' COVID-19 vaccine, for active immunization to prevent coronavirus disease 2019 caused by SARS-CoV-2 in individuals 18 years of age and older.
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South Korea Ministry of Food and Drug Safety Approves Novavax COVID-19 Vaccine
1/12/2022
Novavax, Inc. and SK bioscience, Co. Limited announced that South Korea's Ministry of Food and Drug Safety has approved a Biologics License Application from SK bioscience for Nuvaxovid™ COVID-19 Vaccine for active immunization in individuals 18 years of age and older for the prevention of COVID-19 caused by SARS-CoV-2.
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The FDA informed Johnson & Johnson that adverse-event reports indicated a possible increased risk of immune thrombocytopenia within 42 days after vaccination with their COVID-19 vaccine.
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The 2022 virtual J.P. Morgan Healthcare Conference got off to a roaring start Monday with deal announcements and plans to drive biopharma companies through the coming year.
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Novavax and Serum Institute of India File for Emergency Use Authorization of Novavax' COVID-19 Vaccine in South Africa
1/10/2022
Novavax, Inc. (Nasdaq: NVAX), and Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume, today announced a regulatory submission to the South African Health Products Regulatory Agency (SAHPRA) for emergency use authorization (EUA) of Novavax' recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant.
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Novavax to Participate in the 40th Annual J.P. Morgan Healthcare Conference
1/4/2022
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it will participate in the virtual 40th Annual J.P. Morgan Healthcare Conference.
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Novavax is entering the New Year with final plans for an emergency use authorization application filing to the U.S. FDA for its COVID-19 vaccine, NVX-CoV2373.
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Novavax Submits Final Data Packages to U.S. FDA as Prerequisite to Emergency Use Authorization Application Request for COVID-19 Vaccine
12/31/2021
Novavax Submits Final Data Packages to U.S. FDA as Prerequisite to Emergency Use Authorization Application Request for COVID-19 Vaccine.
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Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in India
12/28/2021
Novavax, Inc. and Serum Institute of India Pvt. Ltd. today announced that the Drugs Controller General of India (DCGI) has granted emergency use authorization (EUA) for Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant.
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Novavax and SK bioscience Expand Manufacturing Agreement
12/23/2021
Novavax, Inc. and SK bioscience, Co. Limited announced the expansion of the companies' collaboration and license agreements for NVX-CoV2373, Novavax' recombinant nanoparticle protein-based COVID-19 vaccine.
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Novavax Announces Initial Omicron Cross-Reactivity Data from COVID-19 Vaccine Booster and Adolescent Studies
12/22/2021
Novavax, Inc. (Nasdaq: NVAX), today announced initial data evaluating the immune response of its COVID-19 vaccine, NVX-CoV2373, against the Omicron variant as well as additional data from its ongoing Phase 2 boost study.
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World Health Organization SAGE Issues Interim Recommendations for Novavax COVID-19 Vaccine
12/21/2021
Novavax, Inc. announced that the World Health Organization Strategic Advisory Group of Experts on Immunization has published its interim recommendations for use of NVX-CoV2373, Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant.
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Novavax Announces Initiation of PREVENT-19 COVID-19 Vaccine Phase 3 Trial Booster Study
12/21/2021
Novavax, Inc. (Nasdaq: NVAX), today announced that the first booster doses of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant, have been administered in an extension of the company's PREVENT-19 pivotal Phase 3 clinical trial.
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World Health Organization Grants Second Emergency Use Listing for Novavax COVID-19 Vaccine
12/20/2021
Novavax, Inc. announced that the World Health Organization has granted a second Emergency Use Listing for NVX-CoV2373, Novavax' recombinant protein nanoparticle COVID-19 vaccine with Matrix-M™ adjuvant, for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.
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Novavax Receives Positive European Medicines Agency Recommendation for Conditional Marketing Authorization of its COVID-19 Vaccine
12/20/2021
Novavax, Inc. today announced that the European Medicines Agency (EMA) has recommended granting a conditional marketing authorization for Novavax' COVID-19 vaccine (also known as NVX-CoV2373) to prevent COVID-19 in people from 18 years of age and older.
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European Commission Grants Conditional Marketing Authorization for Novavax COVID-19 Vaccine
12/20/2021
Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced that the European Commission has granted Novavax conditional marketing authorization for Nuvaxovid™ COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.
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Novavax and Serum Institute of India Announce World Health Organization Grants Emergency Use Listing for NVX-CoV2373 COVID-19 Vaccine
12/17/2021
Novavax, Inc. and Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume, today announced that the World Health Organization (WHO) has granted Emergency Use Listing (EUL) for NVX-CoV2373.
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Full results from the Phase III trial of Novavax's proposed COVID-19 vaccine demonstrated the drug's efficacy in preventing mild, moderate, and severe illness.
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Novavax Announces Submission of New Drug Application in Japan for Approval of COVID-19 Vaccine
12/16/2021
Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced the submission of a New Drug Application to the Ministry of Health, Labour and Welfare in Japan for its COVID-19 vaccine by its partner Takeda Pharmaceutical Company Limited.
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The Pfizer-BioNTech vaccine (now Comirnaty®) was fully approved by the U.S. Food and Drug Administration (FDA) on August 23 and boosters of this shot are now available to the most vulnerable Americans.