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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
The FDA approved only drug in U.S. to treat severe malaria
On May 26, 2020, the FDA approved Amivas’ artesunate for injection to treat severe malaria in adult and…
The FDA approved only drug in the U.S. to treat severe malaria
On May 26, 2020, the FDA provided approval to Amivas for its artesunate for injection to treat severe…
Biotechnology | COVID-19 | Disease | Infectious Disease | Measles | Polio | Therapeutics | Vaccine | WHO
At least 80 million children under one at risk of diseases such as diphtheria, measles and polio as COVID-19 disrupted routine vaccination efforts
On May 22, 2020, COVID 19 disrupted life-saving immunization services around the world, putting millions of children –…
The FDA issued an emergency use authorization (EUA) for the Philips Medizin Systeme Boeblingen
On Apr. 22, 2020, the FDA issued an emergency use authorization (EUA) for the Philips Medizin Systeme Boeblingen…
FDA approved first therapy for children with debilitating and disfiguring rare disease
On Apr. 10, 2020, the FDA approved AstraZeneca ‘s Koselugo (selumetinib) for treatment of pediatric patients, 2 years…
Philips ramped up production of critical health technology products in response to COVID-19 pandemic
On Mar. 22, 2020, Philips announced that Childrenﾒs Hospital of Georgia has adopted Philipsﾒ automated early detection and…
Dr. Claudia Kleinman, Dr. Nada Jabado, and Dr. Michael Taylor discovered that pediatric brain tumors derive from a genetic event early in cellular development
On Nov. 25, 2019, Dr. Claudia Kleinman, Dr. Nada Jabado, and Dr. Michael Taylor discovered that pediatric brain…
UPenn completed exclusive R&D alliance with Novartis
On Sept. 12, 2019, UPenn completed its exclusive, 7-year research and development alliance with Novartis, that spawned the…
Genetically modified babies given go ahead by UK ethics body
On Jul. 18, 2018, the Nuffield Council on Bioethics said that changing the DNA of a human embryo…