Pfizer and BioNTech received positive CHMP ppinion for COMIRNATYﾮ in children 6 months to less than 5 lears in EU
On Oct. 19, 2022, Pfizer and BioNTech announced that the European Medicines Agencyﾒs (EMA) Committee for Medicinal Products…
U.S. FDA recommended Novavax COVID-19 vaccine, adjuvanted as a booster in adults
On Oct. 19, 2022, the U.S. Food and Drug Administration (FDA) recommended the use of the Novavax COVID-19…
EMA’s CHMP for Human Use issued positive opinion recommending authorization for use of Spikevax in children 6 months – 5 years in EU
On Oct. 19, 2022, Moderna announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human…
Moderna announced supply agreement with Gavi that secured access to updated variant-specific COVID-19 vaccines for low-and-middle income countries
On Oct. 17, 2022, Moderna and Gavi, the Vaccine Alliance, announced they had mutually agreed to cancel remaining…
Novavax COVID-19-influenza combination vaccine candidate induced antibody and T-Cell responses against SARS-CoV-2 and influenza
On Oct. 13, 2022, Novavax announced positive results from the Phase 1/2 clinical trial of its COVID-19-Influenza Combination…
Pfizer and BioNTech announced positive early data from clinical trial of Omicron BA.4/BA.5-adapted bivalent booster
On Oct. 13, 2022, Pfizer and BioNTech announced early data from a Phase 2/3 clinical trial (NCT05472038) evaluating…
Gene associated with better immune response and protection after COVID-19 vaccination identified by Oxford researchers
On Oct. 13, 2022, researchers from the University of Oxford reported findings from a study exploring how certain…
Moderna received Authorization for Emergency Use from FDA of Omicron-targeting bivalent COVID-19 booster vaccine for children
On Oct. 12, 2022, Moderna announced that it had received emergency use authorization from the U.S. Food and…
Biotechnology | CDC | COVID-19 | FDA
Pfizer and BioNTech received U.S. FDA EUA for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster in children
On Oct. 12, 2022, Pfizer and BioNTech announced that the U.S. Food and Drug Administration granted Emergency Use…
Intranasal COVID-19 vaccine candidateﾒs clinical data highlighted need for further development of nasal spray vaccines
On Oct. 11, 2022, researchers from the University of Oxford have reported new findings from a Phase 1…
Novavax and SK bioscience filed post approval change application in South Korea for Nuvaxovid COVID-19 vaccine as booster in adults
On Oct. 10, 2022, Novavax announced that partner, SK bioscience, had submitted a Post Approval Change Application to…
Switzerland’s Federal Office of Public Health recommended Novavax Nuvaxovid COVID-19 vaccine as booster in adults
On Oct. 10, 2022, Novavax announced that Switzerland’s Federal Office of Public Health had recommended Nuvaxovid (NVX-CoV2373) as…
Merck and Ridgeback Biotherapeutics provided update on new clinical and non-clinical studies of LAGEVRIOﾙ (molnupiravir)
On Oct. 6, 2022, Merck announced data from two real-world evidence studies evaluating LAGEVRIOﾙ (molnupiravir), an investigational oral…
Washington University in St. Louis COVID-19 nasal vaccine technology licensed to Ocugen
On Oct. 4, 2022, Washington University in St. Louis announced it had licensed the rights to develop, manufacture…
Pfizer and BioNTech completed submission to EMA for Omicron BA.4/BA.5-adapted bivalent vaccinebBooster in children 5 through 11 years of age
On Sept. 28, 2022, Pfizer and BioNTech announced they had completed a submission to the European Medicines Agency…
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…
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…
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…