Veklury (Remdesivir) was first and only approved treatment for pediatric patients under 12 years of age with COVID-19
On Apr. 25, 2022, Gilead Sciences announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental…
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Pfizer and BioNTech data demonstrated high immune response following booster dose of COVID-19 vaccine in children 5 through 11 years of age
On Mar. 14, 2022, Pfizer and BioNTech announced positive results from a Phase 2/3 clinical trial evaluating the…
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Biotechnology | Diagnostics | Non-Profit Research | Oncology | Radiology | Therapeutics | Women's Health
Fred Hutch and Seattle Cancer Care Alliance unite, reshaped relationship with UW Medicine
On Apr. 1, 2022, the Fred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance (SCCA) announced a…
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Researchers generated the first complete, gapless sequence of a human genome
On Mar. 31, 2022, researchers announced they have created a complete, gap-free sequence of the roughly 3 billion…
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Novavax submitted request to expand conditional Marketing Authorization of COVID-19 vaccine in the EU to adolescents
On Mar. 31, 2022, Novavax announced submission of its request to expand the conditional marketing authorization (CMA) of…
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Moderna announced COVID-19 vaccine phase 2/3 study in children 6 months to Under 6 years met Its primary endpoint
On Mar. 23, 2022, Moderna announced positive interim data from the Phase 2/3 KidCOVE study of the Moderna…
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NIH launched program to offer molecular characterization of childhood cancers
On Mar. 21, 2022, in support of the Cancer Moonshot’s goal of fostering data sharing in cancer research,…
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Health Canada authorized Moderna’s COVID-19 vaccine in children (6-11 Years)
On Mar. 17, 2022, Moderna announced that Health Canada had approved the use of Moderna’s mRNA COVID-19 vaccine,…
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CDC reported effectiveness of 2-Dose BNT162b2 mRNA vaccine in preventing SARS-CoV-2 infection among children
On Mar. 11, 2022, the BNT162b2 (Pfizer-BioNTech) mRNA COVID-19 vaccine was recommended by the Centers for Disease Control and…
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Pfizer initiated phase 2/3 study of novel COVID-19 oral treatment in pediatric participants
On Mar. 9, 2022, Pfizer announced that it had initiated a Phase 2/3 study, EPIC-PEDS (Evaluation of Protease…
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Gilead reported phase 2/3 interim data evaluating safety, tolerability and clinical outcomes of Veklury (Remdesivir) in pediatric patients with COVID-19
On Feb. 11, 2022, Gilead Sciences announced new data from an interim analysis of its ongoing, Phase 2/3…
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Veklury (Remdesivir) retained antiviral activity against Omicron, Delta and other emergent SARS-CoV-2 variants
On Feb. 11, 2022, Gilead Sciences announced new data from an interim analysis of its ongoing, Phase 2/3…
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Novavax announced positive results of COVID-19 vaccine in pediatric population of PREVENT-19 phase 3 clinical trial
On Feb. 10, 2022, Novavax announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, achieved its primary effectiveness…
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InteliSwab COVID-19 rapid tests receive U.S. FDA authorization for pediatric use
On Jan. 31, 2022, OraSure Technologies announced that its InteliSwab COVID-19 rapid tests had been authorized by the…
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FDA approved Veklury (Remdesivir) for treatment of non-hospitalized patients at high risk for COVID-19 disease progression
On Jan. 20, 2022, Gilead Sciences announced that the U.S. Food and Drug Administration had granted expedited approval…
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Pfizer received U.S. FDA Emergency Use Authorization for novel COVID-19 oral antiviral treatment
On Dec. 22, 2021, Pfizer announced that the U.S. Food and Drug Administration (FDA) had authorized the emergency…
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FDA authorized long-acting monoclonal antibodies for pre-exposure prevention of COVID-19 in certain individuals
On Dec. 8, 2021, the U.S. Food and Drug Administration issued an emergency use authorization for AstraZenecaﾒs Evusheld…
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SIGA announced Health Canada regulatory approval of Oral TPOXX
On Dec. 1, 2021, SIGA Technologies announced that Health Canada had approved oral TPOXX (tecovirimat) as an extraordinary…
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Biotechnology | COVID-19 | Diagnostics | Infectious Disease | Vaccine | WHO
Global progress against measles threatened amidst COVID-19 pandemic
On Nov. 10, 2021, the World Health Organization (WHO) announced that while reported measles cases had fallen compared…
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Moderna filed to expand the conditional Marketing Authorization for COVID-19 vaccine in the EU to include children ages 6-11 years
On Nov. 9, 2021, Moderna announced that it has submitted for a variation to the conditional marketing authorization…
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Pfizer and BioNTech provided U.S. Government an additional 50 million pediatric doses of COVID-19 vaccine
On Oct. 28, 2021, Pfizer and BioNTech announced that the U.S. government had purchased 50 million more doses…
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LogicBio Therapeutics announced early clinical trial results demonstrated first-ever in vivo genome editing in children
On Oct. 18, 2021, LogicBio Therapeutics announced clinical trial results that demonstrated the first-ever in vivo genome editing…
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Biotechnology | FDA | HIV | Therapeutics
U.S. FDA approved expanded indication of Gilead’s Biktarvy for Treatment of HIV-1 in pediatric populations
On Oct. 18, 2021, Gilead Sciences announced that the Food and Drug Administration had approved a new low-dose…
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Washington University School of Medicine in St. Louis led pediatric COVID-19 vaccine trial launched
On Oct. 6, 2021, Washington University School of Medicine announced the start of a pediatric COVID-19 vaccine clinical…
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COVID-19 | FDA | Therapeutics
FDA broadened existing EUA of Lilly and Incyte’s baricitinib in patients hospitalized with COVID-19
On Jul. 29, 2021, Incyte announced the U.S. Food and Drug Administration (FDA) had broadened the Emergency Use…
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Chimerix received U.S. FDA approval for TEMBEXA (brincidofovir) for treatment of smallpox
On Jun. 4, 2021, The U.S. Food and Drug Administration (FDA) approved Chimerix’s Tembexa (brincidofovir) tablets and oral…
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Merck announced positive topline results from phase 3 pediatric studies for investigational 15-valent pneumococcal conjugate vaccine
On May 20, 2021, Merck announced V114, the company�s investigational 15-valent pneumococcal conjugate vaccine, met its primary immunogenicity…
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Scientists discovered rare genetic condition that attacks kids’ immune systems
On May 19, 2021, Megan A. Cooper, MD, PhD, an associate professor of pediatrics at Washington University School…
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Novavax initiated pediatric expansion for phase 3 clinical trial of COVID-19 vaccine
On May 3, 2021, Novavax announced that it had initiated a pediatric expansion of its Phase 3 clinical…
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BC Study Reports Baby’s first poop predicted risk of developing allergies
On Apr. 29, 2021, researchers at the University of British Columbia (UBC) announced a study published in Cell…
