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…
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…
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)…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
European Commission selected Humanigenﾒs lenzilumab as one of the 10 most promising treatments for COVID-19
On Oct. 25, 2021, Humanigen announced the European Commission had identified lenzilumab as one of the ﾓ10 most…
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,…
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…
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…
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…
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…
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…
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…
U.S. CDC Advisory Committee unanimously recommended Johnson & Johnson COVID-19 vaccine as booster for all eligible individuals
On Oct. 21, 2021, Johnson & Johnson announced that the U.S. Centers for Disease Control and Prevention (CDC)…
Pfizer and BioNTech announced phase 3 trial data showing high efficacy of booster dose of COVID-19 vaccine
On Oct. 21, 2021, Pfizer and BioNTech announced topline results from a Phase 3 randomized, controlled trial evaluating…
INOVIO announced MOU with Colombia for protecting against COVID-19 and broader health initiatives
On Oct. 21, 2021, Inovio Pharma announced the signing of a non-binding memorandum of understanding with Colombia’s Ministry…
Moderna announced FDA authorization of booster dose of COVID-19 vaccine in the U.S.
On Oct. 20, 2021, Moderna announced that the U.S. Food and Drug Administration (FDA) had authorized for emergency…
Johnson & Johnson COVID-19 vaccine booster shot authorized for Emergency Use by U.S. FDA
On Oct. 20, 2021, Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) had issued Emergency…