FDA news in pediatrics: August 2026

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 August 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 August, 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 news in pediatrics: August 2026

1. FDA accepts application to expand clesrovimab-cfor use to high-risk children in second RSV season

On August 6, 2026, the FDA accepted Merck's supplemental biologics license application to expand ENFLONSIA (clesrovimab-cfor) to include children under 2 years who remain at increased risk for severe RSV disease entering a second season, with a PDUFA date of March 22, 2027. Supporting phase 3 SMART trial data showed a season-2 safety profile broadly consistent with the first dose, though the second-season cohort was small and concentrated in children with chronic lung or congenital heart disease.

2. Anaphylm sublingual epinephrine film shows improved usability, comparable PK ahead of planned FDA resubmission

On August 10, 2026, Aquestive Therapeutics reported topline human factors and pharmacokinetic data supporting a planned third-quarter NDA resubmission for Anaphylm (dibutepinephrine) sublingual film, addressing packaging and administration issues cited in a January 2026 Complete Response Letter. Revised packaging cut median pouch-opening time from 17 to 3 seconds and reduced incorrect film placement by more than 80%, with self-administered pharmacokinetics comparable to clinician-administered dosing.

3. FDA review of apitegromab for SMA continues, minus one facility

On August 11, 2026, Scholar Rock announced that the FDA's review of apitegromab's biologics license application for spinal muscular atrophy would proceed using only one of its two proposed fill-finish facilities, after the other received an Official Action Indicated inspection classification; the September 30, 2026, PDUFA date remains unchanged. The application rests on the phase 3 SAPPHIRE trial, which showed statistically significant motor function improvements when apitegromab was added to background SMN-targeted therapy in patients aged 2 to 21 years with nonambulatory SMA.

4. FDA accepts ecopipam NDA with priority review for pediatric Tourette syndrome

On August 19, 2026, the FDA accepted Teva's New Drug Application and granted priority review to ecopipam, a first-in-class selective dopamine D1 receptor antagonist, for pediatric Tourette syndrome, with a target action date in late Q1 2027. Phase 3 data showed a 53% reduction in relapse risk among pediatric responders maintained on ecopipam versus those withdrawn to placebo, without the metabolic or movement-disorder signals associated with existing D2-blocking antipsychotic options.

5. FDA approves nipocalimab as first treatment for warm autoimmune hemolytic anemia

On August 25, 2026, the FDA approved nipocalimab-aahu (Imaavy) for warm autoimmune hemolytic anemia in patients aged 12 years and older who are currently or previously treated with corticosteroids, marking the first therapy specifically indicated for the disease. In the phase 2/3 ENERGY trial, roughly three times as many nipocalimab-treated patients achieved durable hemoglobin response by week 24 versus placebo, though the pediatric portion of the approval relies on extrapolation and pharmacokinetic bridging rather than direct pediatric efficacy data.

6. FDA authorizes first dual glucose-ketone monitor for children as young as 2

On August 25, 2026, the FDA authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System through the De Novo pathway, the first wearable to continuously track both glucose and ketones in a single sensor, cleared for patients with diabetes aged 2 years and older. Data from 6 studies enrolling more than 600 participants showed the device could detect clinically meaningful ketone changes, including elevations preceding the onset of diabetic ketoacidosis.

7. FDA authorizes Avulux light-filtering lenses for migraine-associated light sensitivity in patients 12 and older

On August 26, 2026, the FDA granted De Novo marketing authorization to Avulux precision light-filtering lenses to reduce light sensitivity in patients aged 12 years and older with episodic migraine, establishing a new device classification for the category. The over-the-counter lenses selectively block light at 480 nm and 590 nm wavelengths and are intended to supplement, not replace, existing migraine treatment.

8. FDA approves dolutegravir dispersible tablets for HIV-infected newborns

On August 26, 2026, the FDA approved Tivicay PD (dolutegravir) tablets for oral suspension to treat HIV-1 in newborns from birth, provided they weigh at least 2 kg, lowering the prior 4-week age threshold. The approval was supported by IMPAACT 2023 data from 48 newborns showing drug exposures comparable to those associated with efficacy in adults and a safety profile consistent with older pediatric patients over 16 weeks of follow-up.