Q3 2025: A recap of the top headlines and interviews

Q3 2025: A recap of the top headlines and interviews | Image Credit: © Uladzislau - stock.adobe.com

As we move into the fourth quarter of 2025, Q3 brought several treatment regulatory updates and clinical trial results to help better take care of pediatric patients across the globe.

In the vast realm of pediatric health care, several specialty areas, from dermatology to allergy and immunology to infectious disease, saw newly FDA-approved medicines and updated clinical data for treatments still in development.

In the Q3 recap below, Contemporary Pediatrics highlights some of the top FDA-related action items, clinical trial data, and expert interviews conducted during the third quarter of 2025.

Click on each title below for additional information based on each news article.

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Q3 2025 regulatory updates in pediatrics

FDA approves guselkumab for children with plaque psoriasis and psoriatic arthritis

On September 29, 2025, the FDA approved guselkumab (TREMFYA) for children aged 6 years and older weighing at least 40 kg with moderate to severe plaque psoriasis or active psoriatic arthritis, making it the first IL-23 inhibitor authorized for these pediatric conditions. Backed by the phase 3 PROTOSTAR trial and pharmacokinetic analyses, the approval provides a new treatment option for an estimated 20,000 children with plaque psoriasis and 14,000 with PsA in the United States. Trial data showed significant improvements in skin clearance and symptom control, with a favorable safety profile, addressing an important unmet need for effective, nonsteroidal therapies in young patients.

FDA pulls clearance of Pfizer-BioNTech COVID-19 vaccine for children under 5

On August 27, 2025, the FDA authorized updated COVID-19 vaccines for the 2025–2026 season while significantly restricting use in children. Pfizer’s Comirnaty is now approved only for adults 65 and older and individuals aged 5–64 with underlying conditions, while Moderna’s Spikevax remains available for high-risk children 6 months to 11 years and Novavax’s Nuvaxovid for at-risk patients 12 and older.

The American Academy of Pediatrics (AAP) criticized the move, warning that reduced pediatric access creates dangerous vulnerabilities as respiratory virus season approaches. The AAP reaffirmed its recommendation for vaccination beginning at 6 months and emphasized that decisions should remain between parents and pediatricians.

FDA approves first generic iron sucrose injection for iron deficiency anemia in CKD

On August 12, 2025, the FDA approved Viatris Inc’s iron sucrose injection, USP, as the first generic version of Venofer for the treatment of iron deficiency anemia in adults and children ≥2 years with chronic kidney disease. The intravenous therapy will be available in multiple single-dose vial strengths and received a competitive generic therapy designation for select doses, granting 180 days of market exclusivity.

Viatris emphasized the approval as a milestone for patient access and its generics portfolio, noting the product was developed in-house. Iron sucrose carries risks of serious hypersensitivity reactions, hypotension, and iron overload, requiring patient monitoring. Common adverse effects include gastrointestinal symptoms, headache, dizziness, and injection site reactions, with safety profiles differing slightly between adults and pediatric patients.

FDA approves sebetralstat as first and only on-demand treatment for HAE

On July 7, 2025, the FDA approved sebetralstat (Ekterly; KalVista Pharmaceuticals) as the first oral, on-demand treatment for hereditary angioedema (HAE) attacks in patients 12 years and older.

Previously, HAE treatments required injection. Approval was based on the phase 3 KONFIDENT trial, which showed faster symptom relief and attack resolution with sebetralstat compared with placebo. The therapy was well tolerated and demonstrated a similar safety profile to placebo. The approval follows a delayed review and marks a significant advance in patient-controlled HAE management.

FDA approves gardenia blue as natural color additive for food use

On July 14, 2025, the FDA approved gardenia (genipin) blue as a color additive in food, the fourth natural-source dye authorized in recent months.

The approval allows use in beverages, candies, and teas, supporting efforts to phase out synthetic, petroleum-based dyes. Derived from the gardenia fruit, gardenia blue was approved under section 721 of the FD&C Act following a petition by the Gardenia Blue Interest Group. The decision aligns with HHS’s broader initiative to prioritize natural additives and public health.

Q3 2025 top headlines in pediatrics

CDC reports highest number of pediatric influenza-associated deaths since 2009-10

The 2024–2025 influenza season resulted in 280 pediatric influenza-associated deaths, the second-highest total since child deaths became nationally notifiable in 2004, according to the CDC’s Morbidity and Mortality Weekly Report. Deaths represented a national rate of 3.8 per 1 million children, with the highest mortality observed in infants younger than 6 months (11.1 per 1 million). Most cases involved influenza A viruses (86%), and 89% of vaccine-eligible children who died had not been fully vaccinated. Over half of the cases involved underlying conditions, primarily neurologic, though many deaths occurred in previously healthy children. Median time from symptom onset to death was 4 days, and nearly half of the patients were never hospitalized. Investigators emphasized annual influenza vaccination for all children aged 6 months and older as the most effective prevention strategy and highlighted the need for pediatric vigilance given the potential for rapid deterioration in otherwise healthy patients.

AAP announces updated clinical report to manage food allergy in schools

The AAP has released an updated clinical report on food allergy management in schools, published in Pediatrics. As many as 1 in 10 children are affected by food allergies, with peanuts, tree nuts, milk, eggs, soy, wheat, fish, shellfish, and sesame accounting for the most severe reactions. The report emphasizes accurate diagnosis supported by clinical history, testing, and, when needed, oral food challenges. Pediatricians are advised to provide standardized allergy and anaphylaxis emergency plans to schools, prescribe epinephrine auto-injectors, and support stock epinephrine programs, which have been used in up to 31% of reactions among children without prior diagnoses. The guidance also highlights risk-reduction strategies, including no food-sharing policies, proper handwashing, label reading, and safe classroom practices. In addition to medical management, the report underscores the psychosocial impact of food allergies, recommending anti-bullying initiatives and school-wide education to create safe, supportive environments for children.

HHS to remove thimerosal from all influenza vaccines in the US

The US Department of Health and Human Services (HHS) has adopted CDC recommendations to remove thimerosal from all influenza vaccines for children and pregnant individuals. Only single-dose, mercury-free formulations will be used moving forward, with manufacturers confirming sufficient supply to avoid disruptions.

The update comes amid broader vaccine policy changes, including the CDC’s reaffirmation of annual flu vaccination for everyone 6 months and older and a new recommendation for clesrovimab (Enflonsia) in infants. The announcement follows a lawsuit filed by major medical societies against the HHS and Secretary Robert F. Kennedy Jr, citing concerns over recent immunization policy decisions.

Nirsevimab demonstrates high effectiveness against RSV in healthy-term infants

A large real-world study from Kaiser Permanente Northern California found that nirsevimab was highly effective in preventing respiratory syncytial virus (RSV)–associated lower respiratory tract disease (LRTD) in healthy-term infants during the 2023–2024 season. Among nearly 32,000 infants, those who received nirsevimab had an 87.2% reduced risk of RSV LRTD and a 98.0% reduction in RSV-related hospitalizations compared with nonimmunized infants.

Nirsevimab also significantly reduced RSV-related emergency department visits and overall health care utilization. The findings support current recommendations for routine nirsevimab use in healthy-term infants and highlight its effectiveness across a large, diverse population.

AAP recommends all healthy children 6 months, older receive influenza vaccine

The American Academy of Pediatrics (AAP) has released its influenza vaccine recommendations for the 2025–2026 season, advising vaccination for all individuals 6 months and older. The guidance, published in Pediatrics, includes updates for first-time vaccine recipients, pregnant individuals, and children requiring 2 doses, with an emphasis on timely vaccination by the end of October.

The AAP supports the use of any age-appropriate licensed influenza vaccine and does not recommend delaying vaccination to obtain a specific product, including thimerosal-free options. Pediatric experts stress the importance of vaccination ahead of the school year to protect children from illness and reduce the risk of serious outcomes, including flu-related pediatric deaths.

Q3 2025 expert perspectives in pediatrics

In this section, click the "play" button on each video interview to watch.

Lori Handy, MD, on the importance of vaccine catch-up before the school year

As the new school year approaches, ensuring children are up to date on routine vaccinations remains a key public health priority, says Lori Handy, MD, MSCE, of Children’s Hospital of Philadelphia. She emphasized that school entry has long served as both a timely intervention point for disease prevention and a critical checkpoint for identifying missed care.

Handy noted that the back-to-school period offers families and providers a natural opportunity to review vaccination status, especially for children who may have missed appointments. With schools being high-risk environments for disease spread, she stressed the importance of using this time to catch up on immunizations and protect children as they return to classroom settings.

Special Report: Advances in STI screening and treatments

To mark Sexual Health Awareness Month, Contemporary Pediatrics partnered with Contemporary OB/GYN for a cross-specialty discussion on advances in sexually transmitted infection (STI) screening and management. The session, moderated by Kylee Johnson, MS, APRN, focused on how updated diagnostic tools and regulatory changes affect both maternal and pediatric care.

Neonatal specialist Brooke Redmond, MD, highlighted the pediatric implications of untreated maternal infections, including congenital syphilis, HIV, and neonatal herpes. She noted that pediatricians play a critical role in early detection, follow-up testing, and multidisciplinary collaboration to safeguard infant outcomes.

Diagnostic scientist Denise Haney, PhD, of Roche Diagnostics, outlined how molecular testing platforms are reshaping STI detection, offering higher sensitivity and expanding into at-home collection kits. For pediatric providers, understanding these diagnostic shifts is vital—both for counseling parents and for coordinating care with obstetric colleagues.