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…
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…
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…
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…
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…
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…
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…
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)…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…