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 October monthly 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 October 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: October 2025

1. FDA approves roflumilast cream 0.05% for atopic dermatitis for children aged 2 to 5 years

On October 6, 2025, Arcutis Biotherapeutics announced FDA approval of roflumilast cream 0.05% (Zoryve) for the treatment of atopic dermatitis in children aged 2 to 5 years. The nonsteroidal phosphodiesterase-4 inhibitor is approved for use anywhere on the body for any duration, offering a steroid-free option for young children with widespread disease. Approval was based on phase 3 INTEGUMENT-PED and long-term extension study data demonstrating rapid symptom improvement, durable disease control, and a favorable safety profile—addressing a key unmet need in pediatric dermatology.

2. FDA accepts Afrezza sBLA for pediatric diabetes

On October 13, 2025, MannKind Corporation announced that the FDA accepted its supplemental biologics license application (sBLA) for Afrezza (insulin human) Inhalation Powder, seeking to expand its indication to include children and adolescents with type 1 or type 2 diabetes. If approved, Afrezza would become the first rapid-acting inhaled insulin available for the pediatric population, offering an alternative to injections or insulin pumps. The application is supported by results from the phase 3 INHALE-1 study and has been assigned a PDUFA target action date of May 29, 2026.

3. FDA expands adalimumab-aaty's pediatric indications to include hidradenitis suppurativa, uveitis

On October 17, 2025, Celltrion announced FDA approval of expanded indications for adalimumab-aaty (Yuflyma) and its unbranded version to include the treatment of hidradenitis suppurativa in patients aged 12 years and older and noninfectious uveitis in patients aged 2 years and older. With this label expansion, Yuflyma becomes a treatment option for chronic, burdensome inflammatory conditions in pediatric and adolescent populations, offering a high-concentration, citrate-free, interchangeable biosimilar to Humira that supports broader access to affordable care.

4. FDA approves tezepelumab for CRSwNP in patients 12 years and up

On October 17, 2025, AstraZeneca and Amgen announced FDA approval of tezepelumab (Tezspire) as an add-on maintenance treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) in patients aged 12 years and older. Tezepelumab is now the first and only thymic stromal lymphopoietin (TSLP) inhibitor approved for this indication. The decision was supported by phase 3 WAYPOINT trial data showing significant symptom improvement, reduced need for surgery, and decreased systemic steroid use, addressing a major unmet need in patients with severe, inadequately controlled CRSwNP.

5. FDA issues CRL for SYD-101 to treat progression of pediatric myopia

On October 24, 2025, Sydnexis announced that the FDA issued a complete response letter (CRL) for its new drug application for SYD-101, a low-dose atropine eye drop intended to slow myopia progression in children. While the phase 3 STAR trial met its primary efficacy endpoint, the agency concluded the data did not support overall effectiveness. No safety, manufacturing, or quality deficiencies were cited. If ultimately approved, SYD-101 would be the first FDA-approved treatment for pediatric myopia, addressing a growing unmet need affecting an estimated 28 million U.S. children.

6. FDA accepts pegvaliase-pqpz sBLA to expand treatment to patients with PKU aged 12-17 years

On October 29, 2025, BioMarin Pharmaceutical Inc. announced FDA acceptance of its supplemental biologics license application for pegvaliase-pqp (Palynziq) to expand its indication to adolescents aged 12 to 17 years with phenylketonuria (PKU). The application was granted priority review, with a PDUFA target action date of February 28, 2026. If approved, pegvaliase-pqp would become the first enzyme substitution therapy available for adolescents with PKU in the U.S., offering a new treatment option to reduce toxic phenylalanine levels and ease dietary restrictions during a critical developmental stage.

7. FDA restricts sale of unapproved ingestible fluoride drugs for children

On October 31, 2025, the FDA announced plans to restrict and remove unapproved ingestible fluoride prescription drug products intended for children, citing potential risks to the developing gut microbiome and associations with thyroid dysfunction. The action follows a complete safety review of pediatric fluoride exposure, during which the agency concluded that these products, never formally approved, pose unnecessary systemic risks. While topical fluoride remains supported, the FDA's move aligns with broader efforts to prioritize safe, evidence-based pediatric dental care and may significantly impact prescribing practices for low-risk children.