Epivir-HBV (Lamivudine tablets and oral solution) GlaxoSmithKline

Eylea now also treats retinopathy of prematurity, a leading cause of childhood blindness worldwide.

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 is a once-weekly prescription medication for obesity that has faced supply issues. Its manufacturer, Novo Nordisk, is increasing production capacity in 2023.

If approved, Linzess would be the first prescription therapy for functional constipation in children and adolescents 6 to 17 years of age.

Eylea is being reviewed as a treatment for retinopathy in premature 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.