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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

Moderna announced first participants dosed in phase 2/3 study of COVID-19 vaccine candidate in adolescents
Biotechnology | COVID-19 | Infectious Disease | Vaccine

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…

Read More Moderna announced first participants dosed in phase 2/3 study of COVID-19 vaccine candidate in adolescentsContinue

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

Baricitinib received Emergency Use Authorization from FDA for treatment of hospitalized patients with COVID-19
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…

Read More Baricitinib received Emergency Use Authorization from FDA for treatment of hospitalized patients with COVID-19Continue

Lilly’s neutralizing antibody bamlanivimab received FDA emergency use authorization for treatment of recently diagnosed COVID-19
COVID-19 | FDA | Life Science History

Lilly’s neutralizing antibody bamlanivimab received FDA emergency use authorization for treatment of recently diagnosed COVID-19

On Nov. 9, 2020, the FDA granted Emergency Use Authorization (EUA) for Eli Lilly’s investigational neutralizing antibody bamlanivimab…

Read More Lilly’s neutralizing antibody bamlanivimab received FDA emergency use authorization for treatment of recently diagnosed COVID-19Continue

FDA approved first treatment for COVID-19
COVID-19 | FDA | Life Science History

FDA approved first treatment for COVID-19

On Oct. 22, 2020, the FDA approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric…

Read More FDA approved first treatment for COVID-19Continue

Biotechnology | FDA | Therapeutics

FDA approved first treatment for Ebola virus

On Oct. 14, 2020, the FDA approved Regeneron Pharmaceutical’s Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three…

Read More FDA approved first treatment for Ebola virusContinue

Biotechnology | FDA | Therapeutics

Regeneron’s antibody cocktail REGN-EB3 (Inmazeb) first FDA-approved treatment for Ebola (Zaire Ebolavirus)

On Oct. 14, 2020, Regeneron announced that the FDA had approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the…

Read More Regeneron’s antibody cocktail REGN-EB3 (Inmazeb) first FDA-approved treatment for Ebola (Zaire Ebolavirus)Continue

Veklury (remdesivir) made available directly from distributor
COVID-19 | Life Science History

Veklury (remdesivir) made available directly from distributor

On Oct. 1, 2020, american hospitals began purchasing Veklury (remdesivir) directly from the drugメs distributor. Veklury is an…

Read More Veklury (remdesivir) made available directly from distributorContinue

NIH funded first nationwide network to study rare forms of diabetes
Clinical Research | Disease | NIH | Non-Profit Research | Rare Disease | Therapeutics

NIH funded first nationwide network to study rare forms of diabetes

On Sept. 30, 2020, the National Institutes of Health (NIH) announced funding of a nationwide study to discover…

Read More NIH funded first nationwide network to study rare forms of diabetesContinue

Oxford Immunotec announced FDA clearance of the T-SPOT.TB test for use in pediatrics over the age of two
Disease | FDA

Oxford Immunotec announced FDA clearance of the T-SPOT.TB test for use in pediatrics over the age of two

On Sept. 29, 2020, Oxford Immunotec announced that it had received clearance from the FDA to amend the…

Read More Oxford Immunotec announced FDA clearance of the T-SPOT.TB test for use in pediatrics over the age of twoContinue

Study found that childrenメs immune response protected against COVID-19
COVID-19 | Life Science History

Study found that childrenメs immune response protected against COVID-19

On Sept. 21, 2020, a study comparing the immune responses of adults and children with COVID-19 detected key…

Read More Study found that childrenメs immune response protected against COVID-19Continue

Evidence suggested children could play a larger role in community spread of COVID-19
COVID-19 | Life Science History

Evidence suggested children could play a larger role in community spread of COVID-19

On Aug. 20, 2020, in the most comprehensive study of COVID-19 pediatric patients to date, Harvard Medical School…

Read More Evidence suggested children could play a larger role in community spread of COVID-19Continue

Vaccine refusal and measles outbreaks increased in the U.S.
Biotechnology | Diagnostics | Infectious Disease | Measles | Vaccine

Vaccine refusal and measles outbreaks increased in the U.S.

On Aug. 14, 2020, in the U.S., despite high rates of coverage (>90%) at the national level for…

Read More Vaccine refusal and measles outbreaks increased in the U.S.Continue

The FDA permitted marketing of first game-based digital therapeutic to improve attention function in children with ADHD
Biotechnology | Diagnostics | Disease | FDA | Medical Device | Neurology | Therapeutics

The FDA permitted marketing of first game-based digital therapeutic to improve attention function in children with ADHD

On Jun. 15, 2020, the U.S. Food and Drug Administration (FDA) permitted marketing of the first game-based digital…

Read More The FDA permitted marketing of first game-based digital therapeutic to improve attention function in children with ADHDContinue

The FDA approved drug to treat infants and children with HIV
Biotechnology | CDC | HIV | Therapeutics

The FDA approved drug to treat infants and children with HIV

On Jun. 12, 2020, the U.S. Food and Drug Administration (FDA) approved ViiV Healthcare’s Tivicay (dolutegravir) tablets and…

Read More The FDA approved drug to treat infants and children with HIVContinue

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