Moderna announced mRNA-1345, an investigational RSV Vaccine, had met primary efficacy endpoints in phase 3 trial
On Jan. 17, 2023, Moderna announced positive topline data from its ConquerRSV Phase 3 pivotal efficacy trial of…
BioNTech announced strategic partnership with UK Government to provide up to 10,000 patients with personalized mRNA cancer immunotherapies
On Jan. 5, 2023, BioNTech announced that the Company had signed a Memorandum of Understanding with the Government…
BioNTech and Fosun Pharma announced regulatory approval of mono- and bivalent COVID-19 vaccine COMIRNATYï¾® in individuals 12 years and older in Hong Kong
On Dec. 23, 2022, BioNTech and Fosun Pharmaceutical announced that they had received the certificates of registration as…
Moderna finalized strategic partnership with UK government
On Dec. 21, 2022, Moderna announced the the finalization of a strategic partnership with the UK government to…
EMA Committee for Medicinal Products for Human Use rcommended use of Modernaï¾’s BA.1 bivalent COVID-19 booster in children n the EU
On Dec. 16, 2022, Moderna announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use…
Biotechnology | COVID-19 | FDA | Influenza | Life Science News | Vaccine
Pfizer and BioNTech received U.S. FDA Fast Track Designation for single-dose mRNA-based vaccine candidate against COVID-19 and influenza
On Dec. 9, 2022, Pfizer and BioNTech announced the companies had received Fast Track Designation from the U.S….
Moderna received FDA EUA for Omicron-targeting bivalent COVID-19 booster vaccine in children 6 months through 5 years of age
On Dec. 8, 2022, Moderna announced it had received emergency use authorization from the U.S. Food and Drug…
Pfizer and BioNTech advancd next-generation COVID-19 vaccine
On Nov. 16, 2022, Pfizer and BioNTech announced that the companies had initiated a Phase 1 study to…
Moderna’s BA.4/BA.5 targeting bivalent booster, mRNA-1273.222, met primary endpoint of superiority against omicron variants
On Nov. 14, 2022, Moderna announced that both of Moderna’s bivalent Omicron-targeting booster candidates (mRNA-1273.214 and mRNA-1273.222) trigger…
Pfizer and BioNTech received positive CHMP opinion for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster for children in EU
On Nov. 10, 2022, Pfizer and BioNTech announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine…
Novavax Nuvaxovid COVID-19 Vaccine authorized in the United Kingdom for use as a booster in adults
On Nov. 9, 2022, Novavax announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United…
Moderna received Health Canada authorization for second Omicron-targeting bivalent booster
On Nov. 4, 2022, Moderna announced that Health Canada had authorized the use of its BA.4/BA.5 Omicron-targeting bivalent…
Japan approved partial change to a NDA for Omicron-targeting bivalent booster COVID-19 vaccine
On Oct. 31, 2022, Moderna announced that it had received approval from the Ministry of Health, Labour and…
U.S. FDA recommended Novavax COVID-19 vaccine, adjuvanted as a booster in adults
On Oct. 19, 2022, the U.S. FDA recommended the use of the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) as…
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…
90-Day analysis showed Moderna’s Omicron BA.1-targeting bivalent vaccine, mRNA-1273.214, demonstrated superior antibody response as fourth booster Compared to Spikevax Prototype Booster
On Oct. 19, 2022, Moderna announced new clinical data on its bivalent Omicron-containing booster, mRNA-1273.214. Ninety days after…
Pfizer and BioNTech received positive CHMP ppinion for COMIRNATYï¾® in children 6 months to less than 5 lears in EU
On Oct. 19, 2022, Pfizer and BioNTech announced that the European Medicines Agencyï¾’s (EMA) Committee for Medicinal Products…
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…
Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster received Health Canada authorization for individuals 12 years of age and older
On Oct. 7, 2022, Pfizer and BioNTech announced that Health Canada has authorized COMIRNATY Original & Omicron BA.4/BA.5…
EMA accepted Moderna’s conditional Marketing Authorization filing for omicron BA.4/BA.5 targeting bivalent COVID-19 vaccine
On Sept. 28, 2022, Moderna announced that the European Medicines Agency had accepted a variation for the evaluation…
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…
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…
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…
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 to convert contractually…
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, in collaboration with the U.S. Department…
Moderna announced new supply contract with U.S. Government for 66 million doses of bivalent covid-19 booster vaccine
On Jul. 29, 2022, Moderna announced that the U.S. government has secured 66 million doses of a Moderna…
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…
EMA Committee for Medicinal Products for Human Use recommended use of the Moderna COVID-19 booster in adolescents (12-17 years)
On Jul. 22, 2022, Moderna announced that it had received emergency use authorization from the U.S. Food and…
Yale-developed vaccine offers superior protection against Omicron variants
On Jul. 19, 2022, Yale scientists announced they had developed a novel Omicron-specific mRNA vaccine that offers superior…
TGA granted provisional approval for Moderna’s COVID-19 vaccine in children aged six months to five years
On Jul. 18, 2022, Moderna announced that the Therapeutic Goods Administration (TGA) in Australia had granted provisional registration…