Stelara Gains Pediatric Crohn’s Disease Indication
On April 15, 2026, the US Food and Drug Administration approved an expanded indication for Johnson & Johnson Innovation Medicine’s Stelara® (ustekinumab) for the treatment of moderately to severely active Crohn’s disease in pediatric patients aged two years and older. This approval broadens the existing Crohn’s disease indication of the dual interleukin-12 and interleukin-23 (IL-12/IL-23) inhibitor to include younger pediatric patients. The recommended dose in pediatric patients with Crohn’s disease consists of a single weight‑based intravenous (IV) induction dose, followed by subcutaneous (SC) maintenance dosing every eight weeks. Maintenance dosing is 2.5mg/kg for patients weighing 10kg to 35kg and 90mg for patients weighing more than 35kg. Available in the US since September 2009, Stelara is FDA approved across multiple immune‑mediated inflammatory conditions in adult and pediatric populations. Here is the updated prescribing information.
FDA Expands Tzield Use to Younger Children with Early-Stage Type 1 Diabetes
On April 22, 2026, the FDA approved Sanofi’s Tzield® (teplizumab‑mzwv) to delay the onset of stage three type 1 diabetes (T1D) in children aged one year and older diagnosed with stage two T1D. This approval expands the prior indication, which was limited to patients aged eight years and older. Tzield is an IV monoclonal antibody that is designed to modulate the autoimmune response driving beta‑cell destruction, with the goal of preserving endogenous insulin production. The approval was granted under priority review and supported by one‑year safety and pharmacokinetic data from the phase IV, single‑arm, open‑label trial in children under eight years of age. The dosing regimen follows currently labeled IV administration guidance as a 14-day treatment course with premedication for at least the first five days. No new safety signals were reported in younger children. Updated prescribing information is here.
Dupixent Approved for Children with Chronic Spontaneous Urticaria
The FDA approved Regeneron Pharmaceuticals and Sanofi’s Dupixent® (dupilumab) for the treatment of children aged two to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine therapy on April 22, 2026. This approval expands the prior indication, which was limited to patients twelve years and older marking the first biologic approved for this pediatric CSU population. Approval was supported by extrapolated phase III data from adults and adolescents and pharmacokinetic data from a pediatric phase III trial, in which Dupixent significantly reduced itch and hive activity and well‑controlled disease or complete response rates versus placebo at week 24. For pediatric patients with CSU, Dupixent dosing is weight‑ and age‑based, with children ages two years to five years receiving 200mg or 300mg SC every four weeks without a loading dose and those ages six years to 17 years receiving a weight‑based loading dose followed by maintenance dosing every two or four weeks. The full prescribing information is here.
Ventolin HFA Generic Approved
On April 23, 2026, the FDA approved Cipla’s albuterol sulfate inhalation aerosol (90mcg per actuation) as the first AB‑rated generic therapeutic equivalent of Ventolin® HFA (GlaxoSmithKline). The metered‑dose inhaler is indicated for the treatment or prevention of bronchospasm in adults and pediatric patients aged four years and older with reversible obstructive airway disease, as well as for prevention of exercise‑induced bronchospasm. Until now, Ventolin HFA competition was limited to authorized generics, which are marketed by or under license from the brand manufacturer. The approval of an AB‑rated generic introduces the first opportunity for true generic substitution. Per IQVIA, the US albuterol market is valued at approximately $1.5 billion.