Phase 3 analyses showed that a single dose of REGEN-COV provides long-term protection against COVID-19
On Nov. 8, 2021, Regeneron announced that the European Commission had approved the casirivimab and imdevimab antibody cocktail,…
FDA authorized additional indication for BinaxNOW COVID-19 over-the-counter antigen test
On Nov. 8, 2021, The U.S. Food and Drug Administration (FDA) reissued the emergency use authorization (EUA) for…
Oxford University researchers uncovered gene that doubles risk of death from COVID-19
On Nov. 5, 2021, scientists at Oxford University announced they had identified the gene responsible for doubling the…
Biotechnology | COVID-19 | Diagnostics | Infectious Disease | Therapeutics | USDA | Vaccine | Veterinary
The USDA confirmed COVID-19 in Hyenas at a Colorado Zoo
On Nov. 5, 2021, the USDA’s (USDA) National Veterinary Services Laboratories announced confirmation of SARS-CoV-2 in two spotted…
Pfizer’s COVID-19 oral antiviral treatment candidate reduced risk of hospitalization or death by 89% in interim analysis
On Nov. 5, 2021, Pfizer announced it was investigational novel COVID-19 oral antiviral candidate, PAXLOVID, significantly reduced hospitalization…
Ronapreve approved for additional indication as preventive treatment of symptomatic COVID-19 in Japan
On Nov. 5, 2021, Chugai Pharmaceutical, announced that it had obtained approval from the Ministry of Health, Labour…
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)…
COVID-19 | Nanotechnology | Vaccine | WHO
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)…
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…
Database lock completed for Innovation Pharmaceuticalsﾒ 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…
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 COVAXINﾮ (developed…
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…
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…
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…
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…
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…