Pediatrics

The FDA has proposed new draft guidance to improve the accuracy of pulse oximeters across all skin tones, addressing long-standing concerns about potential disparities in performance.

Crinecerfont, a first-in-class therapy, improved androgen control and reduced reliance on high-dose glucocorticoids for patients with congenital adrenal hyperplasia.

The nasal spray is the first vaccine for the prevention of influenza that does not need to be administered by a health care provider.

The FDA approved givinostat, a nonsteroidal oral medication, for treating patients 6 years of age or older with Duchenne muscular dystrophy.

The FDA approved ustekinumab-auub as an interchangeable biosimilar with ustekinumab for multiple inflammatory diseases.

In late September, the FDA approved the first biosimilar to tocilizumab to treat adult and pediatric patients with various indications of arthritis.

The FDA approved the new round of vaccines for those 12 years and older and authorized emergency use for children 6 months to 11 years of age.

Earlier this year, the FDA approved the same vaccine for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.

The FDA has approved empagliflozin, and empagliflozin and hydrochloride to help manage type 2 diabetes in pediatric patients.

Following three clinical trials, the FDA has approved a new preventive treatment for neonates, infants, and toddlers that prevents respiratory syncytial virus (RSV) in those age populations.