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…
First gene therapy for adults with severe hemophilia A, BioMarin’s ROCTAVIAN, approved by EC
On Aug. 24, 2022, BioMarin Pharmaceutical announced that the European Commission (EC) had granted conditional marketing authorization (CMA)…
Biotechnology | COVID-19 | FDA | Life Science News | Vaccine
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…
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…
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)…
FDA approved first cellbBased gene therapy to treat adult and pediatric patients with Beta-thalassemia
On Aug. 17, 2022, the U.S. Food and Drug Administration approved Zynteglo (betibeglogene autotemcel) developed by bluebird bio,…
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…
Roche announced U.S. FDA approval of Xofluza to treat influenza in children aged five years and older
On Aug. 11, 2022, Roche announced that the U.S. Food and Drug Administration (FDA) had approved a supplemental…
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…
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CDC confirmed first human infection with flu virus from pigs during 2022
On Aug. 5, 2022, the Centers for Disease Control and Prevention (CDC) reported the first human infection with…
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FDA approved first targeted therapy for HER2-low breast cancer
On Aug. 5, 2022, the U.S. Food and Drug Administration (FDA) approved Daiichi Sankyo’s Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV…
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….
AlphaFold revealed the structure of the protein universe
On Jul. 28, 2022, AlphaFold, in partnership with EMBL’s European Bioinformatics Institute (EMBL-EBI), announced they we’re releasing predicted…
Cell by cell, scientists building a high-resolution map of brain changes in Alzheimer’s disease
On Jul. 28, 2022, the Allen Institute announced a newly released dataset of 1.2M cells from brain donors…
WHO recommended long-acting cabotegravir for HIV prevention
On Jul. 28, 2022, the World Health Organization (WHO) released new guidelines for the use of long-acting injectable…
Bacteria that causes rare disease Melioidosis discovered in U.S. environmental samples
On Jul. 27, 2022, the Centers for Disease Control and Prevention (CDC) announced that it had identified for…
Patient with HIV achieved remission following stem cell transplant
On Jul. 27, 2022, City of Hope announced that a 66-year-old man who was diagnosed with HIV in…
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…
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…
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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…
Agriculture | Biotechnology | Diagnostics | Infectious Disease | Influenza | Life Science News | USDA | Veterinary
USDA confirmed highly pathogenic Avian influenza in Florida
On Jul. 22, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) confirmed…
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 the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human…
CDC reported 2021-2022 flu season was relatively mild but longer than usual
On Jul. 22, 2022, the Centers for Disease Control and Prevention (CDC) released a MMWR report that summarized…
Genome of 6,000-year-old wild watermelon sequenced
On Jul. 22, 2022, a team of scientists announced they had sequenced the genome of a 6,000-year-old citrullus…
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A fourth case of HPAI confirmed in Deschutes County, Oregon expanding quarantine
On Jul. 21, 2022, the Oregon Department of Agriculture and the U.S. Department of Agriculture’s Animal Plant Health…
New York State Department of Health and Rockland County Department of Health alerted public to case of polio
On Jul. 21, 2022, The New York State Department of Health confirmed that a case of paralytic poliomyelitis…
Novavax announced expanded agreement with SK bioscience to manufacture COVID-19 vaccine with Omicron variant
On Jul. 19, 2022, Novavax announced that it had signed agreements with its partner, SK bioscience, for the…