© Contemporary Pediatrics

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 June monthly 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 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: June 2025

1. FDA expands Xenoview indication down to 6 years for MRI lung ventilation evaluation

On June 2, 2025, the FDA approved an expanded indication for xenon Xe 129 hyperpolarized (XENOVIEW; Polarean Imaging) for patients aged 6 and older, down from the previous age minimum of 12. The approval also includes new pediatric Dose Delivery Bags and equipment updates to accommodate smaller lungs, enhancing the use of XENOVIEW with MRI to evaluate lung ventilation in children with chronic respiratory conditions.

2. FDA accepts navepegritide application to treat children with achondroplasia

On June 2, 2025, the FDA accepted a new drug application for navepegritide (TransCon CNP; Ascendis Pharma) for the treatment of children with achondroplasia, assigning a Prescription Drug User Fee Act date of November 30, 2025. The once-weekly prodrug delivers sustained CNP exposure to counteract overactive FGFR3 signaling, the underlying cause of the condition. In the phase 2 ApproaCH trial, navepegritide showed superiority over placebo in annualized growth velocity and improvements in bone morphometry, with a favorable safety profile.

3. FDA approves pediatric indication for SONU wearable device to treat nasal congestion

On June 4, 2025, the FDA approved an expanded pediatric indication for the SONU Band (SoundHealth), allowing its at-home use in individuals aged 12 and older for moderate-to-severe nasal congestion caused by allergic and non-allergic rhinitis. The drug-free, AI-enabled device—already De Novo authorized—uses facial scanning and personalized acoustic vibrations to reduce nasal swelling and improve airflow. Clinical data showed the device enhanced CPAP adherence and reduced nasal symptoms, offering a non-invasive alternative for children and families seeking treatments without medication side effects.

4. FDA approves clesrovimab to protect infants during first RSV season

On June 9, 2025, the FDA approved Merck’s clesrovimab (Enflonsia), an extended half-life monoclonal antibody, to protect infants from respiratory syncytial virus (RSV) during their first RSV season. The approval was supported by positive results from the phase 2b/3 CLEVER and phase 3 SMART trials, which demonstrated that a single dose of clesrovimab significantly reduced RSV-related infections and hospitalizations in both healthy and high-risk infants. In the CLEVER trial, clesrovimab reduced medically attended lower respiratory infections by 60.5%, RSV-related hospitalizations by 84.3%, and severe RSV cases by over 90% through 5 months post-dose (P < 0.001 for all). Unlike other monoclonal antibodies, clesrovimab targets site 4 of the RSV fusion protein, neutralizing more than 96% of RSV A and B strains. The therapy, given as a fixed intramuscular dose, offers direct, rapid, and durable protection throughout a typical RSV season.

5. FDA expands glecaprevir/pibrentasvir indication for acute hepatitis C down to 3 years of age

On June 11, 2025, the FDA approved an expanded indication for AbbVie’s glecaprevir/pibrentasvir (Mavyret), allowing its use in patients aged 3 years and older with acute or chronic hepatitis C infection, with or without compensated cirrhosis. This approval made it the first and only 8-week, pangenotypic oral treatment for HCV in this age group. Supported by data showing a 96.2% sustained virologic response, the expanded label enabled earlier treatment at diagnosis and aligned with efforts to eliminate hepatitis C globally, according to AbbVie and public health experts.

6. FDA approves new presentation of ustekinumab-stba biosimilar for plaque psoriasis, psoriatic arthritis

On June 15, 2025, the FDA approved a new presentation of ustekinumab-stba (Steqeyma; Celltrion), a biosimilar to ustekinumab (Stelara), in a 45mg/0.5mL single-dose vial for subcutaneous injection. The new dosage form is indicated for patients aged 6 to 17 years weighing under 60 kg with plaque psoriasis or psoriatic arthritis. With this approval, ustekinumab-stba matched all dosing forms of the reference product. The decision was supported by phase 3 data showing clinical similarity to the reference biologic, with no meaningful differences in safety or efficacy.

7. FDA will not meet original PDUFA date for sebetralstat to treat HAE

The FDA did not meet the June 17, 2025, PDUFA date for a decision on sebetralstat (KalVista Pharmaceuticals), an investigational oral treatment for hereditary angioedema (HAE) in patients aged 12 and older. The delay was attributed to the agency’s limited resources and workload, though no concerns were raised regarding the drug’s safety or efficacy. KalVista stated that the only remaining item under review is final labeling and anticipates a decision within 4 weeks. Sebetralstat previously demonstrated rapid symptom relief and a placebo-like safety profile in phase 3 trials.

8. FDA approves garadacimab-gxii to prevent HAE attacks in patients aged 12 years, older

On June 17, 2025, the FDA approved garadacimab-gxii (Andembry; CSL) for the prevention of hereditary angioedema (HAE) attacks in patients aged 12 years and older. The approval was based on phase 3 VANGUARD trial data showing an 86.5% reduction in monthly attack rate and a median attack rate reduction of more than 99% compared to placebo. Garadacimab-gxii is the first prophylactic HAE treatment to target factor XIIa and was developed entirely by CSL. Interim results from an open-label extension study confirmed sustained efficacy and a favorable long-term safety profile.

9. FDA accepts NDA for epinephrine sublingual film to treat type 1 allergic reactions

On June 17, 2025, the FDA accepted a new drug application for epinephrine sublingual film (Anaphylm; Aquestive Therapeutics) to treat type 1 allergic reactions, including anaphylaxis, and assigned a target action date of January 31, 2026. If approved, Anaphylm would become the first orally-delivered, needle-free epinephrine option available in the United States. The film, which is about the size of a postage stamp, showed consistent pharmacokinetic results in pediatric patients aged 7 to 17 and was well-tolerated with no serious adverse events, according to Aquestive.

10. FDA approves twice-yearly lenacapavir as PrEP for HIV in adolescents, adults

On June 18, 2025, the FDA approved lenacapavir (Yeztugo; Gilead Sciences), a twice-yearly injectable HIV-1 capsid inhibitor, as pre-exposure prophylaxis (PrEP) for adults and adolescents weighing at least 35 kg. Lenacapavir is now the first and only biannual PrEP option in the United States. Approval was based on phase 3 PURPOSE 1 and 2 trials, which showed near-complete protection against HIV acquisition across diverse populations. Gilead highlighted the drug’s potential to improve PrEP adherence and reduce stigma, offering a transformative step forward in HIV prevention.

11. FDA extends review of ruxolitinib cream for pediatric atopic dermatitis

On June 20, 2025, the FDA extended its review of Incyte’s supplemental New Drug Application for ruxolitinib cream 0.75% (Opzelura) to treat mild to moderate atopic dermatitis in children aged 2 to 11 years, shifting the PDUFA date to September 19, 2025. The delay followed a request for additional chemistry, manufacturing, and controls data. The sNDA is supported by positive phase 3 TRuE-AD3 trial results, which showed significant improvements in skin clearance and symptom severity with a favorable safety profile. If approved, it would be the first ruxolitinib formulation available for children under 12 with atopic dermatitis.

12. FDA approves at-home belimumab autoinjector for children with lupus nephritis

On June 24, 2025, the FDA approved a 200 mg/mL autoinjector formulation of belimumab (Benlysta; GSK) for children aged 5 and older with active lupus nephritis, providing the first at-home, subcutaneous biologic treatment option for this condition. The approval builds on prior pediatric and adult indications and aims to reduce treatment burden while maintaining established safety and efficacy. GSK and advocacy leaders emphasized the benefit of offering flexibility and continuity of care for families managing severe pediatric lupus.