The FDA issued an emergency use authorization for the iHealth COVID-19 Antigen Rapid Test
On Nov. 5, 2021, the U.S. Food and Drug Administration The FDA issued an emergency use authorization (EUA)…
Novavax filed COVID-19 vaccine for Emergency Use listing with World Health Organization
On Nov. 4, 2021, Novavax announced the completion of its rolling submission to the World Health Organization (WHO)…
Database lock completed for Innovation Pharmaceuticalsï¾’ phase 2 clinical trial of brilacidin for COVID-19
On Nov. 3, 2021, Innovation Pharma announced that the Company had received confirmation that hard lock of the…
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…
WHO issued emergency use listing for eighth COVID-19 vaccine
On Nov. 3, 2021, the World Health Organization (WHO) issued an emergency use listing (EUL) for COVAXINï¾® (developed…
U.S. FDA authorizd InteliSwabï¾™ COVID-19 rapid tests for at-home testing for delta variant detection
On Nov. 2, 2021, OraSure Technologies announced that the EUA for its InteliSwabï¾™ COVID-19 rapid tests had been…
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…
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…
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…
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…
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 Administrationï¾’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 Humanigenï¾’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…