Spring gave way to summer, and along the way the FDA kept up a brisk pace of approvals, label expansions, and regulatory updates affecting pediatric patients.

In our Q2 2026 recap, we list our top FDA-related news items so you can stay informed in an easy-to-read and quick format.

Take a look at our detailed coverage of FDA-related news from April, May, and June, 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: Q2 2026

1. FDA approves sparsentan for pediatric focal segmental glomerulosclerosis

On April 13, 2026, the FDA granted full approval to sparsentan (Filspari; Travere Therapeutics) for children aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome. FSGS accounts for roughly 12% of pediatric kidney failure cases, and a subgroup analysis of the phase 3 DUPLEX trial—presented at ASN Kidney Week 2025—showed sparsentan produced steeper proteinuria reductions than irbesartan, offering pediatric nephrologists the first targeted oral option for this rare glomerular disease.

2. FDA approves dupilumab for chronic spontaneous urticaria in children as young as 2

On April 22, 2026, the FDA approved dupilumab (Dupixent; Regeneron/Sanofi) for chronic spontaneous urticaria (CSU) in children aged 2 to 11 years who remain symptomatic despite H1-antihistamine therapy. The decision builds on the drug's 2025 approval for patients 12 and older and makes dupilumab the first biologic available in the US for young children with this unpredictable, quality-of-life-limiting skin disease.

3. FDA expands teplizumab age indication down to 1 year for stage 2 type 1 diabetes

On April 22, 2026, the FDA approved a supplemental biologics license application expanding teplizumab (Tzield; Sanofi) to children as young as 1 year with stage 2 type 1 diabetes (T1D), down from the original cutoff of 8 years. First approved in 2022 based on phase 2 TN-10 data showing the disease-modifying antibody delayed median progression to stage 3 T1D by about 2 years versus placebo, teplizumab now reaches a substantially younger at-risk population.

4. FDA approves first gene therapy for genetic hearing loss

On April 23, 2026, the FDA granted accelerated approval to lunsotogene parvec-cwha (Otarmeni; Regeneron) as the first gene therapy for genetic hearing loss caused by biallelic variants in the OTOF gene, an ultra-rare condition affecting about 50 US newborns each year. The one-time, dual-AAV1 vector therapy is delivered surgically into the cochlea to restore otoferlin expression in patients with preserved outer hair cell function and no prior cochlear implant in the treated ear. Among 20 evaluable pediatric and adult patients in the single-arm trial, 80% experienced improved hearing, with some achieving hearing essentially restored to normal. The approval—granted under the FDA's Commissioner's National Priority Voucher pilot program just 61 days after BLA filing—marks the first disease-modifying treatment for OTOF-related deafness, and Regeneron said it will provide the therapy at no cost to eligible US patients.

5. FDA approves insulin glargine-aldy as interchangeable biosimilar for pediatric type 1 diabetes

On May 4, 2026, the FDA approved insulin glargine-aldy (Langlara) as an interchangeable biosimilar to Lantus for adults and pediatric patients with type 1 diabetes, and for adults with type 2 diabetes. Comparable pharmacokinetic, pharmacodynamic, efficacy, safety, and immunogenicity data supported the decision, and as an interchangeable product, Langlara may be substituted for Lantus at the pharmacy level where state law permits—potentially expanding access to basal insulin therapy.

6. FDA expands ASCENIV label to children as young as 2 with primary humoral immunodeficiency

Also on May 4, 2026, the FDA approved a label expansion for ASCENIV (immune globulin), extending its indication to pediatric patients aged 2 years and older with primary humoral immunodeficiency, broadening replacement-therapy options for this population of immunocompromised children.

7. FDA clears OTC Differin Epiduo Gel for acne in patients aged 12 years and older

On May 22, 2026, the FDA approved a prescription-to-OTC switch for Differin Epiduo Acne Gel (adapalene 0.1%/benzoyl peroxide 2.5%; Galderma) for patients aged 12 years and older, moving a topical retinoid–benzoyl peroxide combination that had been prescription-only for more than 15 years onto store shelves. Galderma cited phase 3 data showing the fixed-dose combination outperformed either active ingredient alone or vehicle gel, with up to a 70.3% reduction in inflammatory lesions by week 12. For pediatric clinicians, the switch may change how adolescents initiate acne treatment before seeking medical care, and counseling on appropriate use, expected early irritation, and when to escalate to prescription therapy remains important.

8. FDA approves LINZESS for functional constipation in children 2 to 5 years

On May 27, 2026, the FDA approved an expanded indication for LINZESS (linaclotide; Ironwood Pharmaceuticals) to include children aged 2 to 5 years with functional constipation, making it the only FDA-approved prescription therapy for this condition in that age group. The decision was supported by a 12-week phase 3 placebo-controlled trial showing improved spontaneous bowel movement frequency with linaclotide 72 mcg, and a safety profile consistent with that seen in adults and older pediatric patients. The prescribing information retains a boxed warning against use in children younger than 2 years because of the risk of serious dehydration, and the capsule contents can be mixed with applesauce or water to ease administration in young children.

9. FDA approves inhaled insulin Afrezza for children and adolescents with diabetes

On May 29, 2026, the FDA approved an expanded indication for Afrezza (insulin human inhalation powder; MannKind) to include children and adolescents aged 4 to 17 years with type 1 or type 2 diabetes—the first FDA-approved inhaled insulin for pediatric patients. The decision rested on the phase 3 INHALE-1 trial; although the full intent-to-treat population narrowly missed the prespecified HbA1c noninferiority margin against multiple daily injections, a modified analysis demonstrated noninferiority, and patients reported greater treatment satisfaction along with less weight gain, giving families a needle-free option for mealtime insulin dosing.

10. FDA approves ensitrelvir for post-exposure prevention of COVID-19 in adolescents

On June 2, 2026, the FDA approved ensitrelvir for post-exposure prophylaxis of COVID-19 in patients aged 12 years and older, following positive phase 3 trial results, giving clinicians a new tool for limiting spread after household or close-contact exposure in adolescents.

11. FDA expands marstacimab approval to children ages 6 to 11 with hemophilia

On June 8, 2026, the FDA broadened the indication for marstacimab (Hympavzi; Pfizer) to include pediatric patients aged 6 to 11 years with hemophilia A or B, as well as patients 12 and older with inhibitors, extending this non-factor prophylactic option to a younger range of children living with bleeding disorders.

12. FDA clears new sunscreen ingredient for children 6 months and older

On June 9, 2026, the FDA approved bemotrizinol as a new active sunscreen ingredient under the OTC monograph—the first such clearance in nearly two decades—for use in adults and children as young as 6 months, adding a broad-spectrum UV filter option to the pediatric sun-protection toolkit.

13. FDA approves expanded tocilizumab-bavi indications including pediatric COVID-19

On June 10, 2026, the FDA approved expanded indications for tocilizumab-bavi (Tofidence), adding severe or life-threatening CAR T-cell–induced cytokine release syndrome and hospitalized COVID-19 in patients aged 2 years and older, broadening this biosimilar's use in critically ill children.

14. FDA accepts vedolizumab sBLA for pediatric ulcerative colitis and Crohn's disease

On June 10, 2026, the FDA accepted Takeda's supplemental application for intravenous vedolizumab in patients 2 years and older with moderate-to-severe ulcerative colitis or Crohn's disease, with a PDUFA date set for the first quarter of 2027—a step toward a dedicated pediatric indication for this gut-selective biologic.

15. FDA grants accelerated approval to teplizumab for newly diagnosed stage 3 type 1 diabetes

On June 12, 2026, the FDA granted accelerated approval to teplizumab (Tzield) for a second pediatric indication: delaying further decline of insulin production in patients aged 8 to 17 years recently diagnosed with stage 3 T1D. This marks the first FDA-approved treatment for this indication and a second major pediatric milestone for teplizumab within the same quarter.

16. FDA approves gadoquatrane for low-dose contrast-enhanced MRI

On June 15, 2026, the FDA approved gadoquatrane (Ambelvist), a next-generation macrocyclic gadolinium-based contrast agent that delivers effective CNS and whole-body MRI contrast at 60% less gadolinium than standard macrocyclic agents—a meaningful safety consideration for children who may require repeated imaging.

17. FDA approves generic baloxavir marboxil and clears Capvaxive as supplemental pneumococcal vaccine for at-risk children

In the same week, the FDA approved the first generic version of baloxavir marboxil, a cap-dependent endonuclease inhibitor used for influenza treatment and prophylaxis (June 18, 2026), and cleared Capvaxive as a supplemental pneumococcal conjugate vaccine for at-risk children, based on phase 3 STRIDE-13 data (June 18, 2026)—two decisions aimed at strengthening the respiratory and infectious disease toolkit ahead of the next viral season.

18. FDA approves first generic rifapentine for tuberculosis treatment and prevention

On June 23, 2026, the FDA approved the first generic rifapentine for both treatment and prevention of tuberculosis in patients 12 years and older, a move expected to improve affordability and access to this key component of TB regimens.