New Indication: Hepatitis B indication expanded to pediatric patients
FDA Approves First Pediatric Indication for Blockbuster Eylea
Eylea now also treats retinopathy of prematurity, a leading cause of childhood blindness worldwide.
FDA Accepts BLA for RSV Prevention in Infants
Nirsevimab is a single-dose, long-acting antibody to protect infants from respiratory syncytial virus (RSV) lower respiratory tract infections. The FDA action date is in the third quarter of 2023.
Wegovy Approved for Teens; Supply May be Delayed
Wegovy is a once-weekly prescription medication for obesity that has faced supply issues. Its manufacturer, Novo Nordisk, is increasing production capacity in 2023.
AbbVie Submits sNDA for Linzess for Children and Adolescents
If approved, Linzess would be the first prescription therapy for functional constipation in children and adolescents 6 to 17 years of age.
FDA Grants Six Months Pediatric Exclusivity for Eylea
Eylea is being reviewed as a treatment for retinopathy in premature infants.
FDA Uses Real-World Data to Approve Boostrix for Prevention of Infection in Infants
Regulators used a re-analysis of data from an observational case-control study of Tdap vaccine effectiveness to show that Boostrix given in the third-trimester prevented pertussis among infants.
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