The U.S. Food and Drug Administration accepted a New Drug Application and two supplemental NDAs for Genentech’s Xofluza (baloxavir marboxil).
The U.S. Food and Drug Administration approved Gilead Sciences’ Epclusa for hepatitis C (HCV) for use in children as young as 6 years of age or who weigh at least 17 kilograms.
U.S. presidential candidate Bernie Sanders proposed spending $1.5 trillion over 10 years to create a universal child care and early education system, to be funded by taxing the wealthiest Americans.
Emeryville, California-based Zogenix announced positive topline data from the company’s Phase III trial of Fintepla (fenfluramine) in Lennox-Gastaut Syndrome.
The U.S. Food and Drug Administration regulatory body accepted for priority review the use of Sanofi and Regeneron’s Dupixent product for children aged 6-11 with moderate-to-severe eczema,
The U.S. Food and Drug Administration approved Novo Nordisk’s Fiasp (insulin aspart injection) 100 u/mL for use as a new mealtime insulin option for children with diabetes.
The U.S. Food and Drug Administration approved an expanded indication for Sanofi’s Toujeo (insulin glargine injection) for blood sugar control in adult and pediatric patients who are ages 6 years and older. The expanded indication approved by the FDA applies to both type 1 and 2 diabetes. Previously, Toujeo was U.S.-approved only for adults aged 18 years and older.
The U.S. Food and Drug Administration approved Oxbryta (voxelotor), a drug from Global Blood Therapeutics Inc. developed to treat sickle cell disease in adults and children 12 years or older.
Researchers tested a new drug combo that shows promise for the treatment of the childhood brain cancers diffuse midline gliomas.
Novartis AG won U.S. approval for the company’s experimental sickle cell disease drug Adakveo.