Drug Pipeline News

FDA cleared Earflo for children 2 years and older with negative middle ear pressure, expanding at-home autoinflation options.

The FDA cleared a generic Infuvite Pediatric injection for children receiving parenteral nutrition, adding a new option for hospital supply.

FDA clearance is being sought for roflumilast cream for infants 3 months and older with mild to moderate atopic dermatitis.

The FDA approved lunsotogene parvec-cwha as the first gene therapy for genetic hearing loss caused by biallelic OTOF variants.

The FDA approved dupilumab for children aged 2 to 11 years with chronic spontaneous urticaria, making it the first biologic for young pediatric CSU patients.

FDA expands teplizumab to children aged ≥1 year with stage 2 T1D, enabling earlier intervention to delay progression to insulin dependence.

FDA expands teplizumab (Tzeld) use to children as young as 1 year with stage 2 type 1 diabetes, aiming to delay progression to clinical disease.

The FDA has approved landiolol for patients younger than 18 years with supraventricular tachycardia, expanding access.

The FDA will review a supplemental application for delgocitinib cream in patients aged 12 to 17 years, supported by phase 3 data showing improved outcomes.

FDA fully approves sparsentan for FSGS in children 8 years and older, offering the first targeted option and stronger proteinuria drops than irbesartan.

A review of 6 novel drugs approved by the FDA, with links to coverage from Contemporary Pediatrics and other MJH Life Sciences brands.

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.

A review of 6 drugs approved by the FDA in Q1 2026, with links to coverage from Contemporary Pediatrics.

A review of 4 drugs to be discussed by the US FDA during Q2 2026, with links to coverage from MJH Life Sciences publications.

Get caught up with Contemporary Pediatrics. This list helps you navigate our top stories from the week, all in one place.

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.