Another month has come and gone, and with it, several FDA approvals and regulatory updates related to the ever-evolving landscape of pediatric health care.

In our April 2026 recap, we list our top FDA-related news items in a quick, easy-to-read format so you can stay informed.

Take a look at our detailed coverage of FDA-related news from April and easily stay in touch with our digital newsletters that bring you practical information for today's pediatrician.

Click the title of each story below for our full coverage of that regulatory update.

FDA updates in pediatric care: April 2026

1. FDA approves sparsentan for pediatric FSGS

On April 13, 2026, the FDA granted full approval to sparsentan (Filspari; Travere Therapeutics) for the treatment of focal segmental glomerulosclerosis in pediatric patients aged 8 years and older, marking the first FDA-approved pharmacologic therapy specifically indicated for this rare kidney disease. The decision was supported by phase 3 DUPLEX and phase 2 DUET data demonstrating greater reductions in proteinuria and favorable renal outcomes compared with irbesartan, including in pediatric subgroups. The approval introduces a targeted treatment option for a condition historically managed with off-label immunosuppressive therapies, addressing a significant unmet need in pediatric nephrology.

2. FDA accepts sNDA for delgocitinib in adolescents with chronic hand eczema

On April 15, 2026, the FDA accepted a supplemental new drug application for delgocitinib cream for the treatment of moderate to severe chronic hand eczema in adolescents aged 12 to 17 years, potentially expanding therapeutic options for an underserved population. The submission is supported by phase 3 DELTA TEEN trial data demonstrating that delgocitinib met primary and secondary endpoints, with improvements in disease severity and a favorable safety profile. If approved, the therapy would offer a targeted topical option for adolescents with chronic hand eczema, a condition with limited approved treatments in this age group.

3. FDA approves landiolol for pediatric supraventricular tachycardia

On April 15, 2026, the FDA approved landiolol (Rapiblyk; AOP Health) for the treatment of supraventricular tachycardia in pediatric patients younger than 18 years, marking the first FDA-approved therapy for this indication in children in the United States. The decision was supported by results from the LANDI-PED study, which demonstrated clinically meaningful reductions in ventricular rate and successful conversion to normal sinus rhythm in a subset of patients, with a safety profile consistent with known beta-blocker effects. The approval expands access to an ultra-short-acting intravenous beta-1 selective agent for use in acute and perioperative settings, addressing an unmet need in pediatric cardiac care.

4. FDA approves teplizumab (Tzield) for delay of type 1 diabetes progression in children 1 year and older

On April 22, 2026, the FDA approved a supplemental biologics license application for teplizumab-mzwv (Tzield; Sanofi), expanding its indication to include children as young as 1 year with stage 2 type 1 diabetes to delay progression to stage 3 disease. The decision was supported by interim data from the phase 4 PETITE-T1D study demonstrating the safety and feasibility of use in younger children, extending access to the first disease-modifying therapy for autoimmune type 1 diabetes into an earlier pediatric population. The approval introduces an opportunity for earlier intervention during a critical window of disease progression, with potential to delay insulin dependence and reduce disease burden in young children.

5. FDA approves dupilumab for chronic spontaneous urticaria in children 2 years and older

On April 22, 2026, the FDA approved dupilumab (Dupixent; Regeneron/Sanofi) for the treatment of chronic spontaneous urticaria in children aged 2 to 11 years who remain symptomatic despite H1 antihistamine therapy, making it the first biologic available for this population. The expanded indication was supported by phase 3 LIBERTY-CUPID trial data demonstrating significant reductions in itch severity and urticaria activity, along with pharmacokinetic and safety data from pediatric studies showing a profile consistent with prior indications. The approval introduces a targeted treatment option for young children with uncontrolled CSU, addressing a significant unmet need in a condition with limited therapeutic alternatives.

6. FDA approves first gene therapy for genetic hearing loss

On April 23, 2026, the FDA granted accelerated approval to lunsotogene parvec-cwha (Otarmeni; Regeneron), the first gene therapy for genetic hearing loss caused by biallelic OTOF variants. The decision was supported by phase 1/2 CHORD trial data demonstrating that most treated patients achieved clinically meaningful improvements in hearing sensitivity, with a substantial proportion reaching thresholds consistent with natural hearing. The one-time AAV-based therapy introduces a first-in-class approach to restoring neurosensory function in this ultra-rare condition, with continued approval contingent on confirmatory trial data.

7. Arcutis submits sNDA for roflumilast cream 0.05% in atopic dermatitis for infants as young as 3 months

On April 27, 2026, Arcutis Biotherapeutics announced submission of a supplemental new drug application to the FDA seeking to expand the indication for roflumilast (Zoryve) cream 0.05% to infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis. The application is supported by phase 1 pharmacokinetic data and the phase 2 INTEGUMENT-INFANT trial demonstrating rapid and clinically meaningful improvements in disease severity and itch, with a safety profile consistent with prior pediatric studies. If approved, the once-daily, nonsteroidal PDE4 inhibitor would address a significant unmet need by extending a targeted topical treatment option to infants with limited therapeutic alternatives.

8. FDA clears generic Infuvite Pediatric for IV nutrition support in children

On April 27, 2026, the FDA approved an abbreviated new drug application for a generic version of Infuvite Pediatric Injection (Apotex), a parenteral multivitamin used in intravenous nutrition support for children. The product is eligible for 180-day competitive generic therapy exclusivity and represents an additional supply option in a category where shortages have impacted care. While not a novel therapeutic advance, the approval may improve access and reliability of essential vitamin supplementation for pediatric patients dependent on parenteral nutrition, particularly in neonatal and intensive care settings.

9. FDA clears Earflo for pediatric negative middle ear pressure

On April 29, 2026, the FDA cleared Earflo (Earflo), an at-home device for children aged 2 years and older with negative middle ear pressure, introducing a noninvasive option during the typical watchful waiting period for otitis media with effusion. The device delivers a controlled nasal air puff during swallowing to help open the eustachian tube and equalize pressure, with company-reported data suggesting improvements in middle ear pressure and hearing, as well as reduced need for surgery. The clearance expands access to home-based management strategies for a common pediatric condition, though additional clinical data may further define its role in routine practice.