Moderna filed to expand the conditional Marketing Authorization for COVID-19 vaccine in the EU to include children ages 6-11 years
On Nov. 9, 2021, Moderna announced that it has submitted for a variation to the conditional marketing authorization…
Novan announced favorable preclinical safety data and intent to advance SB019 for treatment of COVID-19
On Nov. 9, 2021, Novan announced promising preclinical safety results with berdazimer sodium in a 14-day GLP repeat…
INOVIO received FDA authorization to proceed with INNOVATE phase 3 segment for COVID-19 vaccine candidate
On Nov. 9, 2021, Inovio Pharma announced that the U.S. Food and Drug Administration (FDA) provided authorization to…
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,…
Amyris announced JV partnership with ImmunityBio for next generation COVID-19 RNA vaccine
On Nov. 8, 2021, Amyris announced announced it had entered into a 50:50 joint venture arrangement with ImmunityBio…
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…
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…
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…
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 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…
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 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…
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Life-Saving Vaccines
Our Life-Saving Vaccines cartoon illustrates four invaluable vaccines that have affected human civilization throughout history from smallpox and…
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Oregon Health & Science University moved forward with hospital expansion
On Oct. 29, 2021, Oregon Health & Science University’s (OHSU) board of directors approved a project to expand…
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…