Novavax and Serum Institute of India announced full product registration in South Africa of Novavax COVID-19 vaccine
On Sept. 13, 2022, Novavax and Serum Institute of India, the world’s largest vaccine manufacturer by volume, announced…
White House Executive Order advanced National Biotechnology and Biomanufacturing Initiative
On Sept. 12, 2022, the White House announced an executive order to advance biotechnology and biomanufacturing towards innovative…
Fred Hutchinson Cancer Center received $78 million gift to support precision oncology
On Sept. 8, 2022, the Fred Hutchinson Cancer Center (FHCRC) announced that Stuart and Molly Sloan had pledged…
Clinical trial evaluating Mpox vaccine began
On Sept. 8, 2022, a clinical trial evaluating alternative strategies for administering the JYNNEOS mpox vaccine to increase…
USDA launched updated web-based dashboard containing information on SARS-CoV-2 variants detected in animals
On Sept. 8, 2022, the U.S. Department of Agricultureﾒs Animal and Plant Health Inspection Service launched an updated…
Malaria booster vaccine showed durable high efficacy in African children, meeting WHO-specified 75% efficacy goal
On Sept. 8, 2022, researchers from the University of Oxford and their partners reported findings from their Phase…
FDA Approved Daxxify, a New Anti-Wrinkle Drug
On Sept. 7, 2022, the U.S. Food and Drug Administration (FDA) announced it had approved Revance Therapeutics’ DAXXIFY…
FDA authorized Quest Diagnostics’ proprietary Monkeypox test for emergency use
On Sept. 7, 2022, Quest Diagnostics announced that it had received emergency use authorization (EUA) from the U.S….
USDA issued positive Regulatory Status Review response for Norfolk Plant Sciences’ Purple Tomato
On Sept. 6, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service had reviewed…
Researchers in China reported embryos with DNA from three people develop normally in first safety study
On Sept. 6, 2022, scientists in China announced that they had conducted the first comprehensive study of the…
Swissmedic authorized Novavax Nuvaxovid COVID-19 vaccine for adolescents aged 12 through 17 and as booster in adults
On Sept. 2, 2022, Novavax announced that Swissmedic, the Swiss Agency for Therapeutic Products, had expanded its temporary…
World Health Organization approved SK bioscience as supplier of Novavax Nuvaxovid COVID-19 vaccine
On Sept. 2, 2022, Novavax announced that the World Health Organization (WHO) had approved a variation to allow…
Novavax Nuvaxovid COVID-19 vaccine recommended by CHMP for expanded conditional Marketing Authorization in EU as booster for adults
On Sept. 1, 2022, Novavax announced that Nuvaxovid (NVX-CoV2373) COVID-19 vaccine had been recommended for expanded conditional marketing…
$838 Million neurosciences center broke ground in Connecticut
On Aug. 31, 2022, the Yale New Haven Hospital broke ground on the $838 million, 505,000 square foot…
Oldest clinical case of Klinefelter Syndrome was detected in a 1,000-year-old Portuguese skeleton
On Aug. 29, 2022, a group of international researchers, coordinated by Dr Jo�o Teixeira at The Australian National…
U.S. Department of Health and Human Services funded U.S.-based production of Smallpox and Mpox vaccine
On Aug. 29, 2022, the U.S. Department of Health and Human Services (HHS) announced it had provided approximately…
Novavax Nuvaxovid COVID-19 vaccine granted expanded conditional marketing authorization in UK for use in adolescents aged 12 through 17
On Aug. 26, 2022, Novavax announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United…
Pfizer and BioNTech completed submission to EMA for Omicron BA.4/BA.5 adapted bivalent vaccine
On Aug. 26, 2022, Pfizer and BioNTech announced they had completed a submission to the European Medicines Agency…
First gene therapy for adults with severe hemophilia A, BioMarin’s ROCTAVIAN, approved by EC
On Aug. 24, 2022, BioMarin Pharmaceutical announced that the European Commission (EC) had granted conditional marketing authorization (CMA)…
Biotechnology | COVID-19 | FDA | Vaccine
Moderna completed application to U.S. FDA for EUA of omicron-targeting bivalent Covid-19 booster vaccine
On Aug. 23, 2022, Moderna announced that it has completed its submission to the U.S. Food and Drug…
Pfizer and BioNTech announced updated COVID-19 vaccine data supporting efficacy in children 6 months through 4 years of age
On Aug. 23, 2022, Pfizer and BioNTech announced updated efficacy results from a Phase 2/3 trial evaluating a…
Democratic Republic of the Congo declared Ebola resurgence in North Kivu
On Aug. 23, 2022, Health authorities in the Democratic Republic of the Congo declared a resurgence of Ebola…
Moderna announced supplying 12 million doses of Omicron-containing bivalent COVID-19 booster vaccines to Government of Canada
On Aug. 23, 2022, Moderna announced that the Government of Canada had exercised its option to purchase an…
Pfizer and BioNTech submitted application to U.S. FDA for EUA of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine
On Aug. 22, 2022, Pfizer and BioNTech announced they had completed a submission to the U.S. Food and…
U.S. FDA granted EUA for Novavax COVID-19 vaccine, adjuvanted for adolescents Aged 12 through 17
On Aug. 19, 2022, Novavax announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) had received expanded emergency use…
Novavax Nuvaxovid COVID-19 vaccine granted expanded provisional approval in New Zealand for adolescents aged 12 through 17
On Aug. 18, 2022, Novavax announced that New Zealand’s Medsafe had granted expanded provisional approval for Nuvaxovid (NVX-CoV2373)…
The White House announced actions to combat Monkeypox outbreak
On Aug. 18, 2022, the White House announced that the HHS had accelerated Phase 4 of its National…
FDA approved first cellbBased gene therapy to treat adult and pediatric patients with Beta-thalassemia
On Aug. 17, 2022, the U.S. Food and Drug Administration approved Zynteglo (betibeglogene autotemcel) developed by bluebird bio,…
GSK awarded $170 million UNICEF contract for malaria vaccine
On Aug. 16, 2022, UNICEF announced that it had awarded a contract for the first ever supply of…
Medicines and Healthcare Products Regulatory Agency authorized Moderna’s Omicron-containing bivalent booster in the UK
On Aug. 15, 2022, Moderna announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK…