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Home / pediatric - Page 4

pediatric

Gilead reported phase 2/3 interim data evaluating safety, tolerability and clinical outcomes of Veklury (Remdesivir) in pediatric patients with COVID-19
Biotechnology | COVID-19 | Therapeutics

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…

Read More Gilead reported phase 2/3 interim data evaluating safety, tolerability and clinical outcomes of Veklury (Remdesivir) in pediatric patients with COVID-19Continue

Veklury (Remdesivir) retained antiviral activity against Omicron, Delta and other emergent SARS-CoV-2 variants
Biotechnology | COVID-19 | Therapeutics

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…

Read More Veklury (Remdesivir) retained antiviral activity against Omicron, Delta and other emergent SARS-CoV-2 variantsContinue

Novavax announced positive results of COVID-19 vaccine in pediatric population of PREVENT-19 phase 3 clinical trial
Biotechnology | COVID-19 | Infectious Disease | Nanotechnology | Vaccine

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…

Read More Novavax announced positive results of COVID-19 vaccine in pediatric population of PREVENT-19 phase 3 clinical trialContinue

FDA approved Veklury (Remdesivir) for treatment of non-hospitalized patients at high risk for COVID-19 disease progression
COVID-19 | FDA | Life Science History

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…

Read More FDA approved Veklury (Remdesivir) for treatment of non-hospitalized patients at high risk for COVID-19 disease progressionContinue

Pfizer received U.S. FDA Emergency Use Authorization for novel COVID-19 oral antiviral treatment
Biotechnology | COVID-19 | FDA | Infectious Disease | Therapeutics

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…

Read More Pfizer received U.S. FDA Emergency Use Authorization for novel COVID-19 oral antiviral treatmentContinue

FDA authorized long-acting monoclonal antibodies for pre-exposure prevention of COVID-19 in certain individuals
COVID-19 | Life Science History

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…

Read More FDA authorized long-acting monoclonal antibodies for pre-exposure prevention of COVID-19 in certain individualsContinue

SIGA announced Health Canada regulatory approval of Oral TPOXX
Biotechnology | FDA | Infectious Disease | Therapeutics | Vaccine

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…

Read More SIGA announced Health Canada regulatory approval of Oral TPOXXContinue

Global progress against measles threatened amidst COVID-19 pandemic
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…

Read More Global progress against measles threatened amidst COVID-19 pandemicContinue

Moderna filed to expand the conditional Marketing Authorization for COVID-19 vaccine in the EU to include children ages 6-11 years
Biotechnology | COVID-19 | FDA | Infectious Disease | Vaccine

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…

Read More Moderna filed to expand the conditional Marketing Authorization for COVID-19 vaccine in the EU to include children ages 6-11 yearsContinue

Pfizer and BioNTech provided U.S. Government an additional 50 million pediatric doses of COVID-19 vaccine
Biotechnology | COVID-19 | Pharmaceutical | Therapeutics | Vaccine

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…

Read More Pfizer and BioNTech provided U.S. Government an additional 50 million pediatric doses of COVID-19 vaccineContinue

U.S. FDA approved expanded indication of Gilead’s Biktarvy for Treatment of HIV-1 in pediatric populations
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…

Read More U.S. FDA approved expanded indication of Gilead’s Biktarvy for Treatment of HIV-1 in pediatric populationsContinue

LogicBio Therapeutics announced early clinical trial results demonstrated first-ever in vivo genome editing in children
Genomics | Life Science History

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…

Read More LogicBio Therapeutics announced early clinical trial results demonstrated first-ever in vivo genome editing in childrenContinue

Washington University School of Medicine in St. Louis led pediatric COVID-19 vaccine trial launched
Biotechnology | COVID-19 | Infectious Disease | Vaccine

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…

Read More Washington University School of Medicine in St. Louis led pediatric COVID-19 vaccine trial launchedContinue

Humanigen submitted all planned modules forpotential conditional Marketing Authorization from UKメs MHRA
COVID-19 | Life Science History

Humanigen submitted all planned modules forpotential conditional Marketing Authorization from UKメs MHRA

On Oct. 1, 2021, Humanigen announced it had submitted all the planned modules as well as a risk…

Read More Humanigen submitted all planned modules forpotential conditional Marketing Authorization from UKメs MHRAContinue

FDA broadened existing EUA of Lilly and Incyte’s baricitinib in patients hospitalized with COVID-19
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…

Read More FDA broadened existing EUA of Lilly and Incyte’s baricitinib in patients hospitalized with COVID-19Continue

Chimerix received U.S. FDA approval for TEMBEXAᆴ (brincidofovir) for treatment of smallpox
FDA | Life Science History

Chimerix received U.S. FDA approval for TEMBEXAᆴ (brincidofovir) for treatment of smallpox

On Jun. 4, 2021, Chimerix announced that the U.S. Food and Drug Administration (FDA) had granted TEMBEXAᆴ (brincidofovir)…

Read More Chimerix received U.S. FDA approval for TEMBEXAᆴ (brincidofovir) for treatment of smallpoxContinue

Merck announced positive topline results from phase 3 pediatric studies for investigational 15-valent pneumococcal conjugate vaccine
Life Science History | Vaccine

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…

Read More Merck announced positive topline results from phase 3 pediatric studies for investigational 15-valent pneumococcal conjugate vaccineContinue

Scientists discovered rare genetic condition that attacks kids’ immune systems
Biotechnology | Diagnostics | Therapeutics

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…

Read More Scientists discovered rare genetic condition that attacks kids’ immune systemsContinue

Novavax initiated pediatric expansion for phase 3 clinical trial of COVID-19 vaccine
Biotechnology | COVID-19 | Infectious Disease | Vaccine

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…

Read More Novavax initiated pediatric expansion for phase 3 clinical trial of COVID-19 vaccineContinue

Baby’s first poop predicted risk of developing allergies
Biotechnology | Diagnostics | Life Science History

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…

Read More Baby’s first poop predicted risk of developing allergiesContinue

Moderna announced an increased global supply for COVID-19 vaccine to up to 3 billion doses in 2022
Biotechnology | COVID-19 | Infectious Disease | Vaccine

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…

Read More Moderna announced an increased global supply for COVID-19 vaccine to up to 3 billion doses in 2022Continue

FDA revoked Emergency Use Authorization for monoclonal antibody bamlanivimab
COVID-19 | FDA | Life Science History

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…

Read More FDA revoked Emergency Use Authorization for monoclonal antibody bamlanivimabContinue

FDA approved first in the world device to treat patients with congenital heart disease
FDA | Life Science History | Medical Device

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…

Read More FDA approved first in the world device to treat patients with congenital heart diseaseContinue

Plans underway for pediatric COVID-19 vaccine trials
COVID-19 | Life Science History | Vaccine

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…

Read More Plans underway for pediatric COVID-19 vaccine trialsContinue

FDA authorized Eli Lilly’s monoclonal antibodies for treatment of COVID-19
COVID-19 | Life Science History

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…

Read More FDA authorized Eli Lilly’s monoclonal antibodies for treatment of COVID-19Continue

CDC study showed 2019-20 flu vaccine effectively prevented hospitalizations and emergency visits in children
Biotechnology | CDC | Infectious Disease | Influenza | Therapeutics

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…

Read More CDC study showed 2019-20 flu vaccine effectively prevented hospitalizations and emergency visits in childrenContinue

Viatris announced FDA tentative approval of pediatric formulation of Dolutegravir under PEPFAR
FDA | HIV | Life Science History

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…

Read More Viatris announced FDA tentative approval of pediatric formulation of Dolutegravir under PEPFARContinue

FDA authorized monoclonal antibodies for treatment of COVID-19
COVID-19 | FDA | Life Science History

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…

Read More FDA authorized monoclonal antibodies for treatment of COVID-19Continue

Regeneron’s REGEN-COV2 ntibody cocktail for COVID-19 received FDA Emergency Use Authorization
COVID-19 | FDA | Life Science History

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…

Read More Regeneron’s REGEN-COV2 ntibody cocktail for COVID-19 received FDA Emergency Use AuthorizationContinue

Lilly’s neutralizing antibody bamlanivimab received interim authorization from Health Canada as treatment for COVID-19
COVID-19 | Life Science History

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…

Read More Lilly’s neutralizing antibody bamlanivimab received interim authorization from Health Canada as treatment for COVID-19Continue

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