Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron XBB.1.5-adapted COVID-19 Vaccine in the European Union
On Aug. 30, 2023, Pfizer and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP)…
COVID-19 vaccination and boosting during pregnancy benefits pregnant women and newborns
On Aug. 11, 2023, a study funded by the National Institute of Allergy and Infectious Diseases (NIAID) reported…
Masters of acclimation: Octopuses adjust to cold by editing their RNA
On Jul. 25, 2023, U.S. National Science Foundation-supported research, led by Joshua Rosenthal of the Marine Biological Laboratory…
Scientists recovered RNA expression profiles from extinct Tasmanian tiger
On Jul. 18, 2023, scientists reported that they had extracted, sequenced, and analyzed historical RNA from muscle and…
Study raised concerns SARS-CoV-2 evolution outpaces vaccine-generated antibodies
On Apr. 27, 2023, a NIAID-led Phase 2 trial compared two Pfizer bivalent mRNA COVID-19 boosters found that…
U.S. FDA approved treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene
On Apr. 25, 2023, the U.S. FDA approved Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis (ALS)…
Moderna finalized agreement with Government of the Republic of Kenya to establish an mRNA manufacturing facility
On Mar. 30, 2023, Moderna and the Government of the Republic of Kenya announced they had finalized an…
Texas A&M scientists disable protective gene In mosquitoes
On Mar. 15, 2023, scientists at Texas A&M announced that a research study: ‘RNA interference is essential to…
Health Canada authorized Moderna’s Omicron-targeting bivalent COVID-19 vaccine in children & Adolescents
On Feb. 17, 2023, Moderna announced that Health Canada had authorized the use of its Omicron-targeting bivalent COVID-19…
Large-scale genetic analysis showed microRNAs in human pancreas associated with diabetes
On Feb. 9, 2023, the National Institutes of Health (NIH) announced that a new large-scale genetic analysis found…
Moderna announced mRNA-1345, an investigational RSV Vaccine, 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 COMIRNATYﾮ 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 United Kingdom (UK)…
EMA Committee for Medicinal Products for Human Use rcommended use of Moderna’s BA.1 bivalent COVID-19 booster in children in 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 | 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…
Biotechnology | Clinical Research | COVID-19 | Diagnostics | Infectious Disease | Therapeutics | Vaccine
Moderna’s BA.4/BA.5 targeting bivalent booster, mRNA-1273.222, met primary endpoint
On Nov. 15, 2022, Moderna reported findings from a Phase II/III clinical trial where bivalent Omicron-targeting booster candidates,…
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. 3, 2022, Health Canada authorized an adapted version of the Moderna Spikevax COVID-19 vaccine that targets…
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. 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…
90-Day analysis showed Moderna’s Omicron BA.1-targeting bivalent vaccine, mRNA-1273.214, demonstrated superior antibody response
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 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…
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 had 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 (EMA) had accepted a variation for the…