FDA revises labeling on extended-release stimulants for ADHD to include weight loss risk
The revised labeling will warn that patients younger than 6 years taking these medications are at greater risk of weight loss.
FDA news in pediatrics: June 2025
A look back at the FDA submissions and regulatory decisions in the pediatric health care space from June 2025.
FDA notifies providers of safety-related changes to prescribing information of maralixibat, odevixibat
The updated labeling includes a new contraindication for patients with prior or active hepatic events.
MNV-201 receives fast track, rare pediatric disease to treat Pearson Syndrome
MNV-201 is being evaluated in phase 2 clinical trials for treatment of the ultra-rare, life-threatening mitochondrial disorder affecting children.
New 2022 data: Pediatric mental health hospitalizations decline overall, increase for females
The total number of pediatric mental health hospitalizations declined in 2022, the first time observed since 2009.
Weekly review: ACIP meets and votes, marstacimab data for hemophilia, and more
Get caught up with Contemporary Pediatrics! This list helps you navigate our top stories from the week, all in one place.
Mercedes Gonzalez, MD, discusses phase 2 trial of roflumilast cream 0.05% for infant atopic dermatitis
Roflumilast cream 0.05% is being studied for mild-to-moderate AD in infants aged 3 months to under 2 years in a new phase 2 trial.
Marstacimab reduces ABR in patients 12 years and up with hemophilia A or B with inhibitors
New phase 3 data support marstacimab’s efficacy and safety in treating hemophilia A or B with inhibitors, expanding its potential use.
Surge in pediatric Mycoplasma pneumoniae hospitalizations reported in 2024
Mycoplasma pneumoniae caused 1 in 2 pediatric pneumonia hospitalizations in 2024, with sharp increases seen across all age groups, according to a recent CDC MMWR report.
ACIP updates: Committee recommends clesrovimab for RSV, reaffirms routine influenza vaccination
The final recommendation sign off decision will go to HHS secretary Robert F. Kennedy Jr.
Andrew Alexis, MD, MPH, highlights positive lebrikizumab-lbkz data for atopic dermatitis
Lebrikizumab demonstrated efficacy and safety in patients with skin of color and moderate-to-severe atopic dermatitis in the ADmirable trial. Trial investigator Andrew Alexis, MD, MPH, reacts.
ACIP: New members meeting June 25-26; AAP liaisons not participating
The American Academy of Pediatrics will continue to hold its own childhood vaccine schedule, as it has since the 1930s.
PNP Perspective: Focus on the positive outcomes of accepting vaccines
Donna Hallas, PhD, PPCNP-BC, CPNP, PMHS, FAANP, FAAN, shares her thoughts on how PNPs can implement evidence-based strategies to encourage parents to vaccinate their children.
Study: School-based treatments stop cavity progression in NYC children
Silver diamine fluoride and atraumatic restorative treatment stopped most cavities in NYC children, showing school-based care can reduce decay.
FDA approves at-home belimumab autoinjector for children with lupus nephritis
The FDA has approved belimumab (Benlysta; GSK) autoinjector for children with lupus nephritis, expanding at-home treatment.
Social media exposure linked to increased cannabis, dual substance use in adolescents
Frequent exposure to cannabis and e-cigarette posts on social media is linked to increased teen cannabis and dual substance use, according to a study published in JAMA.
AAP updates guidance on genetic testing for developmental delay
AAP updates clinical guidance to help pediatricians navigate genetic evaluation of children with global developmental delay or intellectual disability.
Third-trimester hyperglycemia in pregnancy linked to adult obesity in children
A 40-year study found that higher third-trimester glucose levels in insulin-dependent pregnancies were tied to increased obesity risk in adult offspring.
Prenatal exposure to PFAS associated with higher blood pressure in adolescence
Prenatal PFAS exposure was linked to higher adolescent blood pressure according to a recent study.
Weekly review: New PrEP for HIV, new HAE treatment, and more
FDA extends review of ruxolitinib cream for pediatric atopic dermatitis
The FDA has extended the review of ruxolitinib for atopic dermatitis in children 2 to 11 years to September 2025 to evaluate new CMC data.
John Browning, MD, provides practical skincare reminders ahead of summer season
Pediatric dermatologist John Browning, MD, offers practical sun safety tips and guidance for selecting sunscreens, emphasizing the importance of choosing formulations that work for sensitive skin.
Caffeine proposed as a potential tool in reducing risk of SIDS
Caffeine may protect infants from SIDS by reducing oxygen drops, offering a potential new tool alongside safe sleep practices, a recent study suggests.
Potential downstream benefits of RSV preventive measures, with Octavio Ramilo, MD
Octavio Ramilo, MD, joins us once again to discuss potential benefits of RSV vaccination beyond disease prevention, and to explain how to speak with patients about vaccines and uptake.
Discussing phase 3 data of Panzyga for PANS, with Michael Daines, MD
In this video interview, Michael Daines, MD, explains phase 3 data for Panzyga (Octapharma) for pediatric acute- onset neuropsychiatric syndrome (PANS).
John Browning, MD, explains dermatological questions to ask, answer in primary care
John Browning, MD, highlights why pediatricians should feel comfortable prescribing recent non-steroidals, and what questions to ask patients in office.
A headache with a red flag in a 10-year-old girl
The patient described the headache as “pressure-like,” episodes that occurred for 1 to 2 hours with high severity.
FDA approves twice-yearly lenacapavir as PrEP for HIV in adolescents, adults
Lenacapavir is the first twice-yearly option available in the US for those who need or want PrEP, according to Gilead Sciences.
Phase 3 trial of omaveloxolone to treat Friedreich ataxia in children aged 2 to <16 begins
Currently, omaveloxolone (Skyclarys) is approved to treat adults and adolescents aged 16 years and older impacted by FA.
AAP updates guidance on contraception for adolescents
The American Academy of Pediatrics urges clinicians to offer confidential, adolescent-centered contraceptive care using evidence-based, equity-informed approaches.
