Pfizer and BioNTech submitted for U.S. EUA of Omicron BA.4/BA.5-adapted bivalent COVID-19 booster in children under 5 years
On Mar. 1, 2023, BioNTech and Pfizer announced that they had submitted an application to the U.S. Food…
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EMA Committee for Medicinal Products for Human Use rcommended use of Moderna’s BA.1 bivalent COVID-19 booster in children in the EU
On Dec. 16, 2022, Moderna announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use…
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Biotechnology | FDA | Oncology | Therapeutics
FDA granted approval to atezolizumab for alveolar soft part sarcoma
On Dec. 9, 2022, the U.S. Food and Drug Administration (FDA) approved Genentech’s atezolizumab (Tecentriq) for adult and…
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Pfizer and BioNTech submit application to U.S. FDA for EUA of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children under 5 years
On Dec. 5, 2022, Pfizer and BioNTech announced that the companies had submitted an application to the U.S….
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Biotechnology | Disease | FDA | Therapeutics
FDA approved first drug that can delay onset of Type 1 Diabetes
On Nov. 17, 2022, the U.S. Food and Drug Administration (FDA) approved Tzield (teplizumab-mzwv) injection to delay the…
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FDA approved first cellbBased gene therapy to treat adult and pediatric patients with Beta-thalassemia
On Aug. 17, 2022, the U.S. Food and Drug Administration approved Zynteglo (betibeglogene autotemcel) developed by bluebird bio,…
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Novavax filed supplement to a New Drug submission in Canada for Nuvaxovid COVID-19 vaccine for adolescents
On Jun. 23 2022, Novavax announced the filing of a Supplement to a New Drug Submission with Health…
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Pfizer-BioNTech COVID-19 vaccine received FDA Emergency Use Authorization for children 6 months through 4 years of age
On Jun. 17, 2022, Pfizer and BioNTech announced the U.S. Food and Drug Administration (FDA) had granted emergency…
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Pfizer-BioNTech COVID-19 vaccine demonstrated strong immune response in children 6 months to under 5 years of age following third dose
On May 25, 2022, Pfizer and BioNTech announced topline safety, immunogenicity and vaccine efficacy data from a Phase…
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Novavax participated in Oxford University Com-COV3 booster trial of COVID-19 vaccines in adolescents aged 12 through 15
On May 25, 2022, Novavax announced it was participating in a stage of the COVID-19 Vaccine Schedule Combinations…
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Veklury (Remdesivir) was first and only approved treatment for pediatric patients under 12 years of age with COVID-19
On Apr. 25, 2022, Gilead Sciences announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental…
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Pfizer and BioNTech data demonstrated high immune response following booster dose of COVID-19 vaccine in children 5 through 11 years of age
On Mar. 14, 2022, Pfizer and BioNTech announced positive results from a Phase 2/3 clinical trial evaluating the…
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Biotechnology | Diagnostics | Non-Profit Research | Oncology | Radiology | Therapeutics | Women's Health
Fred Hutch and Seattle Cancer Care Alliance unite, reshaped relationship with UW Medicine
On Apr. 1, 2022, the Fred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance (SCCA) announced a…
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Researchers generated the first complete, gapless sequence of a human genome
On Mar. 31, 2022, researchers announced they have created a complete, gap-free sequence of the roughly 3 billion…
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Novavax submitted request to expand conditional Marketing Authorization of COVID-19 vaccine in the EU to adolescents
On Mar. 31, 2022, Novavax announced submission of its request to expand the conditional marketing authorization (CMA) of…
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Moderna announced COVID-19 vaccine phase 2/3 study in children 6 months to Under 6 years met Its primary endpoint
On Mar. 23, 2022, Moderna announced positive interim data from the Phase 2/3 KidCOVE study of the Moderna…
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NIH launched program to offer molecular characterization of childhood cancers
On Mar. 21, 2022, in support of the Cancer Moonshot’s goal of fostering data sharing in cancer research,…
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Health Canada authorized Moderna’s COVID-19 vaccine in children (6-11 Years)
On Mar. 17, 2022, Moderna announced that Health Canada had approved the use of Moderna’s mRNA COVID-19 vaccine,…
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CDC reported effectiveness of 2-Dose BNT162b2 mRNA vaccine in preventing SARS-CoV-2 infection among children
On Mar. 11, 2022, the BNT162b2 (Pfizer-BioNTech) mRNA COVID-19 vaccine was recommended by the Centers for Disease Control and…
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Pfizer initiated phase 2/3 study of novel COVID-19 oral treatment in pediatric participants
On Mar. 9, 2022, Pfizer announced that it had initiated a Phase 2/3 study, EPIC-PEDS (Evaluation of Protease…
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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…
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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…
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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…
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InteliSwab COVID-19 rapid tests receive U.S. FDA authorization for pediatric use
On Jan. 31, 2022, OraSure Technologies announced that its InteliSwab COVID-19 rapid tests had been authorized by the…
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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…
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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…
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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…
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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…
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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…
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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…
