FDA Approved First Gene Therapy for Treatment of Aromatic L-amino Acid Decarboxylase Deficiency
On Nov. 14, 2024, the U.S. Food and Drug Administration approved PTC Therapeutics’ Kebilidi (eladocagene exuparvovec-tneq), an adeno-associated…
U.S. FDA Approved Pfizer’s HYMPAVZI™ (marstacimab-hncq) for Treatment of Adults and Adolescents with Hemophilia A or B
On Oct. 11, 2024, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved HYMPAVZI™ (marstacimab-hncq)…
Biotechnology | Disease | FDA | Neurology | Non-Profit Research | Oncology
FDA Approved Drug Targeting Johns Hopkins-Discovered Brain Cancer Gene Mutation
On Aug. 6, 2024, the U.S. Food and Drug Administration (FDA) announced it had approved vorasidenib (Voranigo, Servier…
FDA approved new antibiotic for three different uses
On Apr. 3, 2024, the U.S. Food and Drug Administration approved Basilea Pharmaceutica’s Zevtera (ceftobiprole medocaril sodium for…
Flu vaccination during pregnancy decreased flu hospitalizations and emergency visits in infants younger than 6 months
On Dec. 18, 2023, the U.S. Centers for Disease Control and Prevention (CDC) announced a study that showed…
CDC | Life Science History | Measles | WHO
Global measles threat continued to grow as another year passed with millions of children unvaccinated
On Nov. 16. 2023, the U.S. Centers for Disease Control and Prevention (CDC) announced that Following years of…
FDA approved first treatment for patients with rare inherited blood clotting disorder
On Nov. 9, 2023, the U.S. Food and Drug Administration approved ‘ Takeda PharmaceuticalsVAdzynma, the first recombinant (genetically…
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…
Purdue nameed 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…
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…
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…
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. FDA approved Gamida Cell’s Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord…
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…
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…
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…
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…
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…
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,…
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…
Vekluryﾮ (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) had approved a…
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…
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…
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…
NIH launched program to offer molecular characterization of childhood cancers
On Mar. 21, 2022, in support of the Cancer Moonshot? goal of fostering data sharing in cancer research,…
Researchers generated the first complete, gapless sequence of a human genome
On Mar. 21, 2022, in support of the Cancer Moonshot goal of fostering data sharing in cancer research,…
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 ProteaseInhibition…
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…
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…
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…
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…