Pfizer and BioNTech submitted data to EMA for vaccination of children 5 to <12 years of age with COMIRNATY
On Oct. 18, 2021, Pfizer and BioNTech announced that the European Medicines Agency’s Committee for Human Medicinal Products…
Pfizer and BioNTech submitted data to EMA for vaccination of children 5 to <12 years of age with COMIRNATY
On Oct. 15, 2021, Pfizer and BioNTech announced they had submitted data supporting the vaccination of children 5…
Moderna announced FDA Advisory Committee unanimously voted in support of EUA for booster dose of COVID-19 vaccine
On Oct. 14, 2021, Moderna confirmed that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological…
CureVac shifted focus of COVID-19 vaccine development to second-generation mRNA technology
On Oct. 12, 2021, CureVac announced the strategic decision to focus its COVID-19 vaccine development towards the development…
Moderna announced state-of-the-art mRNA facility in Africa to manufacture up to 500 million doses per year
On Oct. 7, 2021, Moderna announced it was building a state-of-the-art mRNA facility in Africa with the goal…
2022 Breakthrough Prize in Life Sciences awarded to Penn Medicine mRNA pioneers Drew Weissman and Katalin Karik
On Sept. 29, 2021, the University of Pennsylvania announced that the Breakthrough Prize in Life Sciences was awarded…
Sanofi terminated mRNA COVID-19 vaccine development to focus on recombinant vaccine candidate
On Sept. 28, 2021, Sanofi announced that it had terminated plans for its own mRNA-based COVID-19 vaccine given…
Pfizer announced Study of mRNA-based next generation flu vaccine program
On Sept. 27, 2021, Pfizer announced that the first participants have been dosed in a Phase 1 clinical…
Moderna announced supply agreement with Peru for 20 million doses of Its COVID-19 vaccine
On Sept. 24, 2021, Moderna announced a supply agreement with the government of Peru for 20 million doses…
Biotechnology | COVID-19 | Genomics | HIV | Vaccine
Winners of 2022 Breakthrough Prizes In Life Sciences announced
On Sept. 22, 2021, the Breakthrough Prize Foundation and its founding sponsors announced the 2022 winners of the…
Moderna announces Health Canada approves its COVID-19 vaccine
On Sept. 16, 2021, Moderna announced Health Canada had approved the New Drug Submission (NDS-CV) for SPIKEVAX (elasomeran…
Emergent BioSolutions announced manufacturing agreement with Providence Therapeutics for mRNA COVID-19 vaccine candidate
On Sept. 14, 2021, Emergent BioSolutions announced a five-year contract development and manufacturing (CDMO) services agreement spanning Emergentﾒs…
Twist Bioscience committed to deliver synthetic RNA controls to fight Delta plus variants of COVID-19
On Sept. 14, 2021, Twist Bioscience announced that it had started shipping its synthetic RNA reference controls for…
Resilience to manufacture mRNA for Moderna’s COVID-19 vaccine
On Sept. 8, 2021, National Resilience announced an agreement to manufacture mRNA for the Moderna COVID-19 vaccine. Under…
Biotechnology | COVID-19 | FDA | Pharmaceutical | Therapeutics | Vaccine
Pfizer and BioNTech submitted a variation to EMA with data in support of a booster dose of COMIRNATY
On Sept. 6, 2021, Pfizer and BioNTech announced that they had submitted a variation to the European Medicines…
Moderna announced submission of data to EMA for its COVID-19 vaccine booster
On Sept. 3, 2021, Moderna announced that it had submitted for a conditional marketing approval (CMA) with the…
Moderna announced submission of initial data to U.S. FDA for Its COVID-19 vaccine booster
On Sept. 1, 2021, Moderna announced it had initiated its submission to the U.S. Food and Drug Administration…
Pfizer and BioNTech announced collaboration with Brazil’s Eurofarma to manufacture COVID-19 vaccine doses
On Aug. 26, 2021, Pfizer and BioNTech announced the signing of a letter of intent with Eurofarma Laboratorios,…
Pfizer and BioNTech initiated rolling submission of SBLA to U.S. FDA for booster dose of COMIRNATY in individuals 16 and Older
On Aug. 25, 2021, Pfizer and BioNTech announced the initiation of a supplemental Biologics License Application (sBLA) to…
Pfizer-BioNTech COVID-19 vaccine COMIRNATY received full U.S. FDA approval for individuals 16 years and older
On Aug. 23, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) approved the…
Amyris achieved promising in-vivo results for intranasal delivery of RNA/NLC vaccine
On Aug. 20, 2021, Amyris announced promising in-vivo results in a study of its licensed RNA vaccine through…
NIH scientists developed faster COVID-19 test
On Aug. 16, 2021, scientists at the National Institutes of Health (NIH) announced they had developed a new…
Moderna announced FDA authorization of third dose of COVID-19 vaccine for immunocompromised individuals
On Aug. 13, 2021, Moderna announced that the Food and Drug Administration (FDA) had approved an update to…
NIH launched study of third COVID-19 vaccine dose in kidney transplant recipients
On Aug. 10, 2021, the National Institutes of Health (NIH) announced that a pilot study had begun to…
Moderna and Canada announced collaboration to bring mRNA manufacturing to Canada
On Aug. 10, 2021, Moderna announced a Memorandum of Understanding (MoU) with the government of Canada to build…
Moderna received FDA Fast Track Designation for Respiratory Syncytial Virus vaccine
On Aug. 3, 2021, Moderna announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track…
Twist Bioscience began shipping synthetic RNA positive controls for Delta (B.1.617.2) SARS-CoV-2 variant
On Jul. 22, 2021, Twist Bioscience announced that it had started shipping its synthetic RNA reference controls for…
Biotechnology | COVID-19 | FDA
U.S. FDA granted Priority Review for Biologics License Application for Pfizer-BioNTech COVID-19 vaccine
On Jul. 16, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) had granted…
Moderna announced supply agreement with Argentina for 20 million doses of its COVID-19 vaccine
On Jul. 12, 2021, Moderna announced a supply agreement with the government of Argentina for 20 million doses…
10 million doses of mRNA-based COVID-19 vaccine supplied to Taiwan Region
On Jul. 12, 2021, BioNTech announced that Fosun Industrial Co. had reached advance procurement agreements for the mRNA-based…