U.S. CDC reported high rates of child flu hospitalizations recorded in 2022-2023 season
On Oct. 20, 2023, the U.S. Centers for Disease Control and Prevention (CDC) reported that among children and…
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Purdue named new pediatric cancer research center for the late Tyler Trent
On Oct. 14, 2023, Purdue University ensured that the memory of the former graduate and devoted Boilermaker football…
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European Commission expanded Merck’s ERVEBO [Ebola Zaire vaccine] indication to include children 1 year of age and older
On Sept. 7, 2023, Merck announced that the European Commission (EC) had approved an expanded indication for ERVEBO…
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COVID-19 vaccination and boosting during pregnancy benefits pregnant women and newborns
On Aug. 11, 2023, a study funded by the National Institute of Allergy and Infectious Diseases (NIAID) reported…
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Biotechnology | Disease | FDA | Medicine | Therapeutics
U.S. FDA approved first gene therapy for treatment of patients with Duchenne Muscular Dystrophy
On Jun. 22, 2023, the U.S. Food and Drug Administration (FDA) approved Sarepta Therapeutics’s Elevidys, the first gene…
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U.S. FDA approved new class of medicines to treat pediatric type 2 diabetes
On Jun. 20, 2023, the U.S. Food and Drug Administration (FDA) approved Boehringer Ingelheim’s Jardiance (empagliflozin) and Synjardy…
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Study found COVID-19 mRNA booster vaccinations in early pregnancy did not increase miscarriage risk
On May 19, 2023, HealthPartners Institute researchers have published new data in JAMA Network Open that shows monovalent…
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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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EC expanded Merck’s VAXNEUVANCE indication to include infants, children and adolescents
On Oct. 24, 2022, Merck announced that the European Commission had approved an expanded indication for VAXNEUVANCE (Pneumococcal…
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EMA’s CHMP for Human Use issued positive opinion recommending authorization for use of Spikevax in children 6 months – 5 years in EU
On Oct. 19, 2022, Moderna announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human…
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Biotechnology | CDC | COVID-19 | FDA | Infectious Disease | Vaccine
Pfizer and BioNTech received U.S. FDA EUA for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster in children
On Oct. 12, 2022, Pfizer and BioNTech announced that the U.S. Food and Drug Administration granted Emergency Use…
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Novavax Nuvaxovid COVID-19 vaccine became available in Israel for individuals aged 12 and older
On Sept. 16, 2022, Novavax announced that the Israel Ministry of Health has granted an import and use…
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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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