152 million babies born preterm in the 2010-20 decade
On May 9, 2023, United Nations agencies and partners reported that an estimated 13.4 million babies were born…
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Biotechnology | FDA | Therapeutics | Vaccine
U.S. FDA approved PREVNAR 20, Pfizer’s 20-valent pneumococcal conjugate vaccine for infants and children
On Apr. 27, 2023, Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved PREVNAR 20®…
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Biotechnology | FDA | Oncology | Radiology | Stem Cell
U.S. FDA approves cell therapy for patients with blood cancers to reduce risk of infection after stem cell transplantation
On Apr. 17, 2023, the U.S. Food and Drug Administration (FDA) approved Gamida Cell’s Omisirge (omidubicel-onlv), a substantially…
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Pfizer RSV vaccine 82% effective vs severe infection in infants, final data showed
On Apr. 5, 2023, Pfizer announced that experimental respiratory syncytial virus (RSV) vaccine was 82% effective in preventing…
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FDA authorized bivalent Pfizer-BioNTech COVID-19 vaccine as booster dose for certain children 6 months through 4 years of age
On Mar. 14, 2023, the U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) of…
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Amphastar Pharmaceuticals received FDA approval for Naloxone hydrochloride nasal spray
On Mar. 8, 2023, Amphastar Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) had granted approval…
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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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Pfizer and BioNTech announced updated COVID-19 vaccine data supporting efficacy in children 6 months through 4 years of age
On Aug. 23, 2022, Pfizer and BioNTech announced updated efficacy results from a Phase 2/3 trial evaluating a…
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FDA approved first cell Based gene therapy to treat adult and pediatric patients with Beta-thalassemia
On Aug. 17, 2022, the U.S. Food and Drug Administration announced it had approved Zynteglo (betibeglogene autotemcel), the…
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Novavax announced initiation of phase 2b/3 Hummingbird global clinical trial for COVID-19 vaccine in children aged six months through 11 years
On Aug. 4, 2022, Novavax announced the initiation of its Phase 2b/3 Hummingbird global clinical trial. The trial…
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Australia TGA granted provisional approval for Moderna’s COVID-19 vaccine in children aged six months to five years
On Jul. 19, 2022, Moderna said that Australia’s drug regulator Therapeutic Goods Administration (TGA) has provisionally approved its…
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Health Canada authorized Moderna’s COVID-19 vaccine in young children (6 months-5 years)
On Jul. 14, 2022, Health Canada announced it had authorized the use of the Moderna Spikevax COVID-19 vaccine…
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Pfizer and BioNTech submitted a variation to EMA for vaccination of children ages 6 months to less than 5 Years with COMIRNATY
On Jul. 8, 2022, Pfizer and BioNTech announced that the companies had submitted a variation to the European…
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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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U.S. FDA approved Merck’s VAXNEUVANCE for prevention of invasive pneumococcal disease in infants and children
On Jun. 22, 2022, Merck announced that that the U.S. Food and Drug Administration (FDA) had approved an…
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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,…
