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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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Biotechnology | FDA | Oncology | Rare Disease | Therapeutics
Ultragenyx and Kyowa Kirin Announce U.S. FDA Approval of Crysvita® (burosumab) for Treatment of Tumor-Induced Osteomalacia
On Jun. 18, 2020, Ultragenyx Pharmaceutical and Kyowa Kirin announced that the U.S. Food and Drug Administration (FDA)…
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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…
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Biotechnology | CDC | FDA | HIV | Therapeutics
The FDA approved drug to treat infants and children with HIV
On June 12, 2020, the U.S. Food and Drug Administration (FDA) approved Tivicay (dolutegravir) tablets and Tivicay PD…
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Biotechnology | FDA | HIV | Therapeutics
ViiV Healthcare announced FDA approval of the first-ever dispersible tablet formulation of dolutegravir for children living with HIV
On Jun. 12, 2020, ViiV Healthcare, a GSK company, with Pfizer and Shionogi Limited, announced the FDA had…
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NIH funded study to evaluate drugs prescribed to children with COVID-19
On Jun. 10, 2020, researchers funded by the National Institutes of Health (NIH) launched an effort to evaluate…
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Biotechnology | Diagnostics | Disease | Genomics | NIH | Therapeutics
NIH researchers uncovered genes linked to common recurrent fever n children
On Jun. 8, 2020, researchers at the National Human Genome Research Institute announced they had discovered clues to…
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The FDA approved only drug in U.S. to treat severe malaria
On May 26, 2020, the U.S. Food and Drug Administration (FDA) announced it had approved Amivas’ artesunate for…
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The FDA approved only drug in the U.S. to treat severe malaria
On May 26, 2020, the U.S. Food and Drug Administration (FDA) approved artesunate for injection to treat severe…
