Drug Pipeline News

The FDA has updated its approval for 1-mg epinephrine nasal spray, removing the age limit to allow all patients weighing at least 33 lb to access the treatment.

This new once-weekly intravenous therapy aims to treat the neurologic manifestations of Hunter syndrome in young children.

Palynziq provides a significant new genotype-independent therapy for patients 12 years and older to help manage and reduce blood phenylalanine levels.

A first-of-its-kind approval for hypothalamic obesity offers earlier, targeted treatment in children.

FDA green-lights Imcivree for acquired hypothalamic obesity in patients 4 years and older, delivering major reductions in BMI and hunger in phase 3.

Aristides Maniatis, MD, FAAP explains how Sogroya reduces treatment burden and improves adherence for pediatric patients with growth disorders.

The FDA sanctioned Johnson & Johnson’s once-daily oral pill for adults and adolescents with moderate to severe plaque psoriasis.

Secukinumab now treats moderate to severe hidradenitis suppurativa in patients 12 years and older, making it the first IL‑17A biologic option for teens.

The approval marks the first treatment option for patients with this rare condition.

The expanded approval provides young pediatric patients with a proven, effective treatment to significantly reduce dangerously high LDL-C levels.

The approval offers a new genotype-independent treatment option for patients aged 12 years and older, significantly reducing blood phenylalanine levels.

FDA okays once-weekly navepegritide for children with achondroplasia, boosting growth with strong trial data; rollout expected early Q2 2026.

The FDA has approved once-weekly somapacitan-beco for children aged 2.5 years and older with 3 separate growth indications.

The FDA has approved desmopressin acetate, the first formulation designed for individualized dosing in patients with central diabetes insipidus.

The approval marks the first FDA-authorized treatment for allergic fungal rhinosinusitis, with trial data showing significant improvements in outcome measures.

The gadopiclenol extension for use in infants and neonates offers high-quality MRI contrast enhancement at half the standard gadolinium dose.

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Phase 3 KEPLER data showed vedolizumab achieved remission in nearly half of children with ulcerative colitis, with consistent safety and durable benefit.

FDA expands pitolisant indication to include cataplexy in patients 6 years and older with narcolepsy.

Ferric maltol gains FDA approval for children 10 years and older with iron deficiency, supported by phase 3 pediatric data.

Phase 2 data suggest FcRn blockade may reduce maternal IgG and placental antibody transfer in HDFN without excess infant infections.

Open-label data show sustained seizure reduction, stable safety, and improved quality of life in LGS treated with fenfluramine.

A study found that a nirsevimab immunization program reduced RSV-related hospitalizations by 85.9% in the first season and 55.3% in the second.

Phase trials show that Breztri Aerosphere triple therapy reduces annual severe exacerbation rates vs dual-combination inhaled therapy.

In the PROPEL 3 trial, oral infigratinib significantly increased annualized height velocity and improved body proportionality in children with achondroplasia.