INOVIO further expanded INNOVATE phase 3 trial for COVID-19 DNA vaccine candidate INO-4800 in India
On Nov. 3, 2021, Inovio Pharma announced that it had received authorization from India’s Central Drugs Standard Control…
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U.S. FDA authorizd InteliSwabﾙ COVID-19 rapid tests for at-home testing for delta variant detection
On Nov. 2, 2021, OraSure Technologies announced that the EUA for its InteliSwabﾙ COVID-19 rapid tests had been…
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NIH announced study of long-term effects of COVID-19 in pregnancy
On Nov. 2, 2021, the National Institutes of Health announced support for a four-year follow-up study on the…
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FDA cleared the first 510(k) for a COVID-19 test, the BioFire COVID-19 Test 2
On Nov. 1, 2021, the U.S. Food and Drug Administration (FDA) cleared the first 510(k) for a COVID-19…
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TGen case study documented first reported U.S. transmission of COVID from a pet owner to pets
On Nov. 1, 2021, for the first time in the U.S., the transmission of COVID-19 from pet parent…
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Novavax filed for COVID-19 vaccine authorization with Health Canada and completed submission to EMA
On Nov. 1, 2021, Novavax announced the completion of its rolling submission to Health Canada for authorization of…
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Novavax and Serum Institute of India receive Emergency Use Authorization for COVID-19 vaccine in Indonesia
On Nov. 1, 2021, Novavax and Serum Institute of India announced that the National Agency of Drug and…
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Moderna updated timing of U.S. Emergency Use Authorization of its COVID-19 vaccine for adolescents
On Oct. 31, 2021, Moderna announced that the U.S. Food and Drug Administration (FDA) had notified the Company…
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Novavax filed for provisional approval of its COVID-19 vaccine in Australia
On Oct. 29, 2021, Novavax announced the completion of its rolling submission to the Therapeutic Goods Administration (TGA)…
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Pfizer and BioNTech received first U.S. FDA EUA of COVID-19 vaccine in children ages 5 through 11 years
On Oct. 29, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) had authorized…
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CDC | COVID-19 | Diagnostics | Vaccine
U.S. CDC study showed vaccination offered higher protection than previous COVID-19 infection
On Oct. 29, 2021, the Centers for Disease Control and Prevention (CDC) published “new science” reinforcing that vaccination…
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Pfizer and BioNTech provided U.S. Government an additional 50 million pediatric doses of COVID-19 vaccine
On Oct. 28, 2021, Pfizer and BioNTech announced that the U.S. government had purchased 50 million more doses…
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Merck and MPP announced agreement for Molnupiravir, investigational oral antiviral COVID-19 medicine, to low- and middle-income countries
On Oct. 27, 2021, the Medicines Patent Pool (MPP) and Merck announced a voluntary licensing agreement to facilitate…
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Hologic’s Multiplex COVID-19/Flu Test became commercially available in North America and Europe
On Oct. 27, 2021, Hologic announced that its Aptima SARS-CoV-2/Flu Assay was available for the simultaneous detection and…
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Novavax filed for authorization of its COVID-19 vaccine in the United Kingdom
On Oct. 27, 2021, Novavax announced the completion of its rolling regulatory submission to the U.K. Medicines and…
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Monoclonal antibody treatment highly effective at reducing COVID-19 hospitalizations
On Oct. 27, 2021, researchers published interim results in The New England Journal of Medicine from a Phase…
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Fulgent Genetics launched at-home neutralizing antibody test for COVID-19
On Oct. 27, 2021, Fulgent Genetics announced that it had launched an antibody test for COVID-19 which specifically…
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Vaxart dosed first subject in phase II COVID-19 oral tablet vaccine clinical trial
On Oct. 26, 2021, Vaxart announced that it has dosed the first subject in its Phase II COVID-19…
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Moderna announced MOU to supply up to 110 million doses of Its COVID-19 vaccine to the African Union
On Oct. 26, 2021, Moderna announced a new Memorandum of Understanding (MoU) to make up to 110 million…
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FDA Advisory Committee votes in favor of granting EUA for Pfizer-BioNTech Covid-19 vaccine in children 5 to <12 years
On Oct. 26, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administrationﾒs (FDA) Vaccines and…
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Moderna announced Swissmedic authorized booster dose of Moderna’s COVID-19 vaccine
On Oct. 26, 2021, Moderna announced that Swissmedic had authorized a booster dose of Spikevax, the Company’s vaccine…
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Axcella Therapeutics launched clinical program to develop treatment for patients with long COVID
On Oct. 26, 2021, Axcella Therapeutics announced a new clinical program to investigate AXA1125 as a potential treatment…
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Moderna announced positive top line data from phase 2/3 study of COVID-19 vaccine in children 6 to 11 years of age
On Oct. 25, 2021, Moderna announced positive interim data from the Phase 2/3 study, called the KidCOVE study,…
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Moderna announced EMA’s CHMP recommended booster dose of Moderna’s COVID-19 vaccine in the European Union
On Oct. 25, 2021, Moderna announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human…
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COVID-19 infection presents greater risk of causing very rare neurological events than vaccines
On Oct. 25, 2021, scientists at Oxford University reported that Infection with COVID-19 carried a much higher risk…
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Merck and Ridgeback initiated rolling review by EMA for Molnupiravir, investigational oral antiviral medicine, for treatment of COVID-19
On Oct. 25, 2021, Merck and Ridgeback Biotherapeutics announced the European Medicines Agency (EMA) had initiated a rolling…
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The Department of Veterans Affairs expanded mandate for COVID-19 vaccines among VHA employees
On Oct. 22, 2021, the U.S. Department of Veterans Affairs (VA) announced that it had begun offering Moderna…
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HHS invested over $560 million to bolster product manufacturing to increase supply, availability of COVID-19 tests
On Oct. 22, 2021, the Department of Health and Human Services (HHS), announced that it had invested more…
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COVID-19 booster increased antibody responses, was protective in rhesus macaques
On Oct. 21, 2021, the National Institutes of Health announced that a booster dose of the mRNA-1273 COVID-19…
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Ligand and CR Double-Crane entered agreement to develop oral COVID-19 therapeutic
On Oct. 21, 2021, Ligand Pharmaceuticals announced the signing of a collaboration agreement granting China Resources Double-Crane Pharmaceutical…
