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 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 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 news in pediatrics: June 2026

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.