Study confirmed link between COVID-19 vaccination and temporary increase in menstrual cycle length
On Sept. 27, 2022, the National Institutes of Health (NIH) announced that a large international study had confirmed…
Novavax made one million doses of Nuvaxovid available for use in the United Kingdom
On Sept. 27, 2022, Novavax announced that an initial one million doses of Nuvaxovid (NVX-CoV2373) COVID-19 vaccine were…
Biotechnology | COVID-19 | FDA
Pfizer and BioNTech submitted application to U.S. FDA for EUA of Omicron BA.4/BA.5-adapted bivalent vaccine booster in children 5 through 11 years of age
On Sept. 28, 2022, Pfizer and BioNTech announced they have completed a submission to the U.S. Food and…
Pfizer to supply global fund up to 6 million PAXLOVID treatment courses for low-and-middle-income countries
On Supt. 22, 2022, Pfizer announced an agreement to supply up to six million treatment courses of its…
Novavax Nuvaxovid COVID-19 vaccine received expanded EUA in Taiwan for use in adolescents aged 12 through 17
On Sept. 16, 2022, Novavax announced that the Taiwan Food and Drug Administration had granted expanded emergency use…
Novavax Nuvaxovid COVID-19 vaccine became available in Israel for individuals aged 12 and older
On Sept. 16, 2022, Novavax announced that the Israel Ministry of Health had granted an import and use…
WHO expanded recommendation for Vekluryﾮ (Remdesivir) to patients with severe disease in update to COVID-19 guideline
On Sept. 15, 2022, Gilead Sciences announced updates to the World Health Organizationﾒs Therapeutics and COVID-19: living guideline,…
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…
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…
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…
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 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…
Moderna completed application to U.S. FDA for EUA of omicron-targeting bivalent Covid-19 booster vaccine
On Aug. 22, 2022, the Food and Drug Administration (FDA) amended the emergency use authorization (EUA) of Moderna…
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)…
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…
Novavax Nuvaxovid COVID-19 vaccine approved in South Korea for use in adolescents aged 12 through 17
On Aug. 12, 2022, Novavax announced that partner, SK bioscience, had received a Post Approval Change Application approval…
Moderna’s Omicron-containing bivalent booster candidate, mRNA-1273.214, demonstrated higher neutralizing antibody response
On Aug. 9, 2022, Moderna announced an amendment to its agreement with the European Commission (EC) to convert…
Novavax announced initiation of phase 2b/3 Hummingbird global clinical trial for COVID-19 vaccine in children aged six months through 11 years
On Aug. 4, 2022, Novavax announced the initiation of its Phase 2b/3 Hummingbird global clinical trial. The trial…
HHS announced 66 million doses of Moderna’s variant-specific COVID-19 vaccine booster for potential use in Fall and Winter 2022
On Jul. 29, 2022, the U.S. Department of Health and Human Services (HHS), in collaboration with the U.S….
Pfizer and BioNTech announced clinical trial of next-generation vaccine candidate based on enhanced spike protein design
On Jul. 27, 2022, Pfizer and BioNTech announced that the companies had initiated a randomized, active-controlled, observer-blind, Phase…
Novavax announced expanded approval of Nuvaxovid COVID-19 vaccine for adolescents aged 12 through 17 in Japan
On Jul. 26, 2022, Novavax announced that Nuvaxovid (NVX-CoV2373) COVID-19 vaccine had received expanded manufacturing and marketing approval…
Novavax Nuvaxovid COVID-19 vaccine granted provisional registration in Australia for use in adolescents aged 12 through 17
On Jul. 26, 2022, Novavax announced that the Australian Therapeutic Goods Agency had granted expanded approval for provisional…
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COVID-19 Vacations Redux
COVID-19 Vacations Redux iIlustrates once again the pits and perils vacation travelers face as they begin their Summer…
CHMP adopted positive opinion recommending Vekluryﾮ (Remdesivir) receive full Marketing Authorization for teatment of patients with COVID-19
On Jul. 22, 2022, Gilead Sciences announced that the Committee for Medicinal Products for Human Use (CHMP) of…