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. He joined the brand in March of 2023 as an editor before being promoted to senior editor in January 2024. Fitch graduated from Youngstown State University in Youngstown, Ohio in 2020 with a degree in telecommunications and journalism. He started his career as a news and sports videographer before becoming an on-air sports anchor at the NBC-affiliated news station in Youngstown. Fitch briefly worked as a national content writer for a Chicago-based national television station before joining the 

team. He can be reached at: jfitch@mjhlifesciences.com.

Articles

As families prepare for a new school year, pediatricians are essential in helping parents navigate immunization schedules and school requirements and ensuring vaccine confidence.

Aligning vaccinations with the start of a new school year 

Cary M. Wright, MD, MS, is a recent graduate of the University of Illinois College of Medicine at Chicago and is an intern at the Stanford Pediatrics Residency Program in California

 and joined the MJH Life Sciences team in December 2019. She graduated from Youngstown State University in 2019 with a bachelor's degree in journalism and a minor in political science. Prior to graduating, Morgan worked as the editor-in-chief of her college newspaper. She went on to work as an assignment editor at a broadcast news station in Youngstown, Ohio before joining 

 You can reach her at mpetronelli@mjhlifesciences.com.

Despite their frequency, it can be challenging to distinguish between types of bites. Can you identify the source of this bite mark? 

Puzzler poll: Can you identify this bite? 

Get caught up with Contemporary Pediatrics! This list helps you navigate our top stories from the week, all in one place. 

Media and mental health, hemophilia approval, July FDA recap, and more

New CDC data show fewer kindergartners are fully vaccinated as exemption rates increased during the 2024-2025 school year.

CDC: Kindergarten vaccination decreases, exemptions increase 

Contemporary Pediatrics connects pediatricians with peer-reviewed articles, guideline updates, and practice strategies for real-world clinical application.

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Infants, young children, and older adults are at the highest risk for pneumococcal infection, and viral illnesses, such as influenza, may predispose sensitive groups to pneumococcal infection.

Pneumococcal conjugate vaccine: A glimpse into current recommendations

**Editor's Note** Please note that starting January 1, 2025, we will be switching to an online-exclusive publication process. This will allow us to publish case submissions quicker without having to deal with the variables that come along with print publication. All cases will still be eligible for print publication consideration, but publication in our print magazine is not guaranteed and will be up to the editor's discretion. 

Do you have a puzzling pediatric case that you’d like to share with the readers of 

We are looking for intriguing diagnoses that have stumped the experts—a diagnostic “Puzzler”—to help our physicians enhance their day-to-day practices. If you have such a story to tell, tell us.

Here’s what to do: Before you begin, we suggest that first you review the Puzzler 

https://www.contemporarypediatrics.com/case-studies

. Please note the specific style required for writing Puzzler manuscripts.

Next, prepare a draft of your case, including a summary of the presenting symptoms, a case overview, a 

table of the differential diagnosis (MANDATORY)

, and the special aspects of your case that qualify it as a Puzzler, and send it to us. Please note that the differential diagnosis table should also be discussed in the body text. We’ll review your draft and let you know what you need to add or revise before we send the manuscript to peer review for evaluation.

Puzzlers vary in length, and we suggest a minimum of 1,200 words up to a maximum of 2,000 words, but that is because of the complexity of some cases and whether some patients returned for many assessments before their diagnoses were determined. Also, some authors describe the pathophysiology of the differentials in great detail. Please also note no more than 3 authors are allowed per article.

What's most important is to show us the process that you used to analyze the case, including:

Why you decided to order certain tests and why you did not order others.

Peer consultations or why you elected to contact other specialists.

Lab values including vital signs or blood tests.

Labs and values if your patient was attended to in the emergency department or other hospital departments such as radiology or neurology.

Discussion related to the possible diagnoses.

Final diagnosis, treatment, prognosis, and follow-up.

Remember to indicate numbered citations within the body of the text and include a complete list of corresponding literature/references at the end of the manuscript. (Do not use any citation management programs or unlink them.) 

Limit references to 25. No references (unless it is a seminal study) can be older than 10 years.

We prefer primary research as references, but some cases are so obscure that authors will need to pull from a variety of sources. However, 

. Be advised that peer reviewers are adamant that the disease/disorder you describe was actually diagnosed and not determined by index of suspicion on the basis of ruling out various differentials. We use AMA11 as our publication style, which uses superscript citation numbers and a corresponding numbered reference list. Please create your citations and references in this style.  Check this recent article posted online at 

https://www.contemporarypediatrics.com/view/the-rx-of-adhd

 for examples of reference style. IMPORTANT NOTE WITH AMA 11TH EDITION: PLEASE PUT DOI OR WEBSITES/URLS AT THE END OF THE REFERENCE LINE.

When you send your draft manuscript, also 

. These image files must be high-resolution jpg or tiff files (minimum of 300 dpi) and as large in size as possible. We suggest a minimum of 7 horizontal inches. The images must be original photos with clear permissions to use, not images from copyrighted sources. Send as separate attachments with your e-mail submission; do not embed images into your manuscript document.

After we receive your manuscript, our editors and peer reviewers will review your draft and let you know if we accept your submission for publication. 

Puzzler is one of the departments for which we receive the most submissions, so it may be several months after submission before you receive feedback from us.

If we do accept your submission for publication, we will contact you with further instructions.

Send your submissions in Microsoft Word format to 

, via e-mail to mpetronelli@mjhlifesciences.com

Guidelines for PUZZLER, 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 July 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 July and easily stay in touch with 

 that bring you practical information for today's pediatrician.

Click the title of each story below for our full coverage of that regulatory update.

1. FDA revises labeling on extended-release stimulants for ADHD to include weight loss risk

The FDA will update labeling for all extended-release attention-deficit/hyperactivity disorder (ADHD) stimulants to include warnings about weight loss risk in children under 6 years, the agency announced in July 2025.

Though not approved for this age group, these medications are often prescribed off-label. FDA findings showed higher plasma exposure and increased adverse events, including significant weight loss, in young children taking extended-release amphetamine and methylphenidate. As a result, new limitations of use will be added or revised to reflect these risks, and clinicians are advised to monitor growth and consider alternative treatments when managing ADHD in this population.

2. 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.

3. FDA accepts NDA for ET-600, desmopressin oral solution for pediatric AVP deficiency

On July 8, 2025, the FDA accepted Eton Pharmaceuticals’ new drug application for ET-600, an oral liquid formulation of desmopressin for treating central diabetes insipidus (AVP-D) in pediatric patients.

The NDA has a target action date of February 25, 2026. If approved, ET-600 would be the first FDA-approved oral liquid desmopressin for children, addressing dosing challenges associated with current therapies and meeting a significant unmet need in pediatric endocrinology.

4. 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.

5. J&J submits icotrokinra NDA for plaque psoriasis in patients 12 years or older

On July 21, 2025, Johnson & Johnson submitted a new drug application to the FDA for icotrokinra, an investigational oral peptide targeting the IL-23 receptor, for moderate to severe plaque psoriasis in patients 12 years and older.

The submission is supported by positive results from four phase 3 trials in the ICONIC program, which showed significant skin clearance and a favorable safety profile. If approved, icotrokinra would be the first oral IL-23–targeting therapy for psoriasis, offering a new, once-daily option for patients seeking effective, noninjectable treatment.

6. FDA grants fast track designation to SGT-501 gene therapy for CPVT

On July 23, 2025, the FDA granted fast track designation to Solid Biosciences’ investigational gene therapy SGT-501 for catecholaminergic polymorphic ventricular tachycardia (CPVT), a rare and potentially fatal inherited arrhythmia.

SGT-501 uses an AAV-based vector to deliver a functional CASQ2 gene to heart muscle cells, aiming to stabilize calcium regulation disrupted in CPVT. The therapy also holds orphan drug and rare pediatric disease designations. With no FDA-approved treatments currently available for CPVT, SGT-501 may offer a first-in-class precision approach targeting the underlying genetic cause.

7. FDA approves avatrombopag for pediatric immune thrombocytopenia, including new sprinkle formulation

On July 28, 2025, the FDA approved avatrombopag (Doptelet) for treating thrombocytopenia in pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) unresponsive to prior therapy.

The approval includes a new oral granule formulation, Doptelet Sprinkle, for children aged 1 to under 6 years. Supported by phase 3 trial data, Doptelet demonstrated significant platelet response and was well tolerated. This marks the first pediatric approval for the oral thrombopoietin receptor agonist, expanding treatment options with flexible, age-appropriate formulations.

8. FDA approves sepiapterin to treat phenylketonuria in adult, pediatric patients

On July 28, 2025, the FDA approved sepiapterin (Sephience; PTC Therapeutics) to treat phenylketonuria (PKU) in both adult and pediatric patients, including infants as young as 1 month with sepiapterin-responsive hyperphenylalaninemia (HPA).

The approval, supported by phase 3 APHENITY trial data, includes broad labeling across PKU subtypes. Sepiapterin, used alongside a phenylalanine-restricted diet, significantly increased natural protein intake while maintaining blood phenylalanine control, offering a new therapeutic option that may help reduce reliance on medical formula and improve quality of life for patients across all ages.

9. FDA approves pegcetacoplan as first treatment for C3 glomerulopathy or IC-MPGN

On July 28, 2025, the FDA approved pegcetacoplan (Empaveli; Apellis Pharmaceuticals) as the first treatment for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years and older.

The approval, based on results from the phase 3 VALIANT study, showed a 68% reduction in proteinuria and stabilization of kidney function. Pegcetacoplan also demonstrated substantial clearance of C3 deposits. This marks a significant advance for patients with these rare kidney diseases, who previously had no FDA-approved treatment options.

A look back at the FDA submissions and regulatory decisions in the pediatric health care space from July 2025.

News

FDA news in pediatrics: July 2025

Multiple medical societies, including the American Academy of Pediatrics (AAP), are suing the US Department of Health and Human Services (HHS) and Secretary Robert F. Kennedy Jr. in an effort to defend vaccine policy, the societies stated, amid recent changes to COVID-19 vaccine recommendations and the removal of members of the CDC's Advisory Committee on Vaccine Practices (ACIP).

The AAP, American College of Physicians (ACP), American Public Health Association (APHA), Infectious Diseases Society of America (IDSA), Massachusetts Public Health Alliance (MPHA), Society for Maternal-Fetal Medicine (SMFM), and a pregnant physician announced the suit via a joint press release on July 7, 2025. 

In the announcement, the joint societies reference the CDC's May 27, 2025, 

 for routine COVID-19 vaccination among healthy individuals and pregnant women. Kennedy Jr. took to the social media platform X to announce that he "couldn't be more pleased to announce that, as of today, the COVID vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule."

CDC pulls COVID-19 vaccine recommendation for healthy children, pregnant individuals

Additionally, the medical societies referenced the firing of 17 ACIP board members, who were replaced Kennedy-appointed personnel "who have historically espoused anti-vaccine viewpoints," according to the joint press release.

The lawsuit charges that a coordinated set of actions by the HHS and Kennedy were "designed to mislead, confuse, and gradually desensitize the public to anti-vaccine and anti-science rhetoric, and that he has routinely flouted federal procedural rules," the collective societies wrote in the announcement. 

Several plaintiffs provided quotes related to the decision to sue HHS and Kennedy Jr., including Sue Kressly, MD, FAAP, president of the AAP, who stated:
"The [AAP] is alarmed by recent decisions by HHS to alter the routine childhood immunization schedule. These decisions are founded in fear and not evidence, and will make our children and communities more vulnerable to infectious diseases like measles, whooping cough, and influenza. Our immunization system has long been a cornerstone of U.S. public health, but actions by the current administration are jeopardizing its success. As we pursue action to restore science to U.S. vaccination policy, AAP will continue to provide the science-based, trusted recommendations that every American deserves.”

' Editor-in-Chief, Tina Tan, MD, FIDSA, FPIDS, FAAP, who is also the Infectious Diseases Society of America's president, added: 
"The [IDSA] will fight to ensure that all individuals of every age have access to life-saving vaccines. We will not stand by while a single federal official unilaterally and effectively strips Americans of their choice to vaccinate with actions that thoroughly disregard overwhelming scientific evidence and decades of established federal processes. As a community of clinicians, public health officials, and scientists, our focus remains the protection of patients and public health.”

1. AAP, ACP, APHA, IDSA, MPHA, and SMFM Join Together to Stop Assault on Public Health. Press release. July 7, 2025. Accessed July 7, 2025. https://www.contemporarypediatrics.com/view/acip-updates-committee-votes-5-2-to-recommend-clesrovimab-to-protect-against-rsv

2. Fitch J. ACIP updates: Committee recommends clesrovimab for RSV, reaffirms routine influenza vaccination. Contemporary Pediatrics. June 26, 2025. Accessed July 7, 2025. https://www.contemporarypediatrics.com/view/acip-updates-committee-votes-5-2-to-recommend-clesrovimab-to-protect-against-rsv

Six medical societies, including the American Academy of Pediatrics, are suing the HHS and its Secretary to "defend vaccine policy."

AAP, other medical societies sue HHS, Robert F. Kennedy Jr. over vaccine practices

July 2025 brought new insights and policy shifts with direct implications for pediatric prevention, infectious disease management, and early risk assessment.

Key updates include the federal removal of thimerosal from influenza vaccines, strong real-world data supporting nirsevimab’s effectiveness against respiratory syncytial virus, and the American Academy of Pediatrics' formal guidance on flu vaccination ahead of the school year. Experts also emphasized the importance of routine vaccine catch-up during back-to-school visits while new research highlighted the potential of genetic screening to identify children at higher risk for obesity.

 reviews the most significant developments shaping pediatric practice and public health. Click each title below for full coverage.

1. HHS to remove thimerosal from all influenza vaccines in the US

Take a quick look at everything you may have missed last month, including the top FDA approvals and latest clinical updates.

Ann McArn, PharmD

Articles

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