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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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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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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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…
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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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Study suggested no association between antiseizure drugs used during pregnancy and neurodevelopmental problems in children at age 2
On Jun. 7, 2021, the National Institutes of Health announced new findings published in JAMA Neurology that suggested…
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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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Scientists discovered a new genetic form of ALS in children
On Jun. 1, 2021, in a study of 11 medical-mystery patients, an international team of researchers led by…
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Pfizer and BioNTech received first authorization in European Union for COVID-19 vaccine in adolescents
On May 28, 2021, Pfizer and BioNTech announced that the Conditional Marketing Authorization for COMIRNATY in the European…
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GSK and Vir Biotech announced sotrovimab (VIR-7831) received EUA from the US FDA for treatment of mild-to-moderate COVID-19 in high-risk adults and paediatric patients
On May 26, 2021, GlaxoSmithKline and Vir Biotechnology announced the U.S. Food and Drug Administration (FDA) granted an…
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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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Gene therapy restored immune function in children with rare immunodeficiency
On May 10, 2021, the National Institutes of Health (NIH) reported that an investigational gene therapy can safely…
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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…
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Moderna announced an increased global supply for COVID-19 vaccine to up to 3 billion doses in 2022
On Apr. 29, 2021, Moderna announced it was making new funding commitments to increase supply at its owned…
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FDA revoked Emergency Use Authorization for monoclonal antibody bamlanivimab
On Apr. 16, 2021, the FDA revoked the emergency use authorization (EUA) that allowed for Eli Lilly’s investigational…
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FDA approved first in the world device to treat patients with congenital heart disease
On Mar. 26, 2021, the U.S. Food and Drug Administration (FDA) approved the first in the world non-surgical…
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Research highlighted risks of separating newborns from mothers during COVID-19 pandemic
On Mar. 16, 2021, research from the World Health Organization (WHO) and partners showed that the COVID-19 pandemic…
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Moderna announced participants dosed in phase 2/3 study of COVID-19 vaccine in pediatric population
On Mar. 16, 2021, Moderna announced that the first participants had been dosed in the Phase 2/3 study,…
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Plans underway for pediatric COVID-19 vaccine trials
On Feb. 18, 2021, Washington University pediatric infectious diseases doctors announced plans to launch clinical trials in the…
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FDA authorized Eli Lilly’s monoclonal antibodies for treatment of COVID-19
On Feb. 9, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab…
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CDC study showed 2019-20 flu vaccine effectively prevented hospitalizations and emergency visits in children
On Jan. 27, 2021, a U.S. Centers for Disease Control and Prevention (CDC) study found that the 2019-2020…
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Moderna announced first participants dosed in phase 2/3 study of COVID-19 vaccine candidate in adolescents
On Dec. 10, 2020, Moderna announced that the first adolescent participants had been dosed in the Phase 2/3…
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Viatris announced FDA tentative approval of pediatric formulation of Dolutegravir under PEPFAR
On Nov. 23, 2020, Viatris announced tentative approval from the FDA for a New Drug Application for pediatric…
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FDA authorized monoclonal antibodies for treatment of COVID-19
On Nov. 21, 2020, the FDA issued an emergency use authorization (EUA) for Regeneron Pharmaceuticals’ casirivimab and imdevimab…
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Regeneron’s REGEN-COV2 ntibody cocktail for COVID-19 received FDA Emergency Use Authorization
On Nov. 21, 2020, Regeneron announced that the antibody cocktail casirivimab and imdevimab administered together (also known as…
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Lilly’s neutralizing antibody bamlanivimab received interim authorization from Health Canada as treatment for COVID-19
On Nov. 20, 2020, Eli Lilly announced that Health Canada had granted authorization under the Interim Order Respecting…
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Biotechnology | COVID-19 | FDA | Therapeutics
Baricitinib received Emergency Use Authorization from FDA for treatment of hospitalized patients with COVID-19
On Nov. 19, 2020, Eli Lilly and Incyte announced that the FDA had issued an Emergency Use Authorization…
