Get caught up with Contemporary Pediatrics! This list helps you navigate our top stories from the week, all in one place.
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Thank you for visiting the Contemporary Pediatrics® website. Take a look at some of our top stories from the week (Monday, June 30, to Friday, July 4, 2025), and click on each link to read and watch anything you may have missed.
On June 30, 2025, the FDA granted both fast track and rare pediatric disease designations to Minovia Therapeutics' investigational cell therapy MNV-201 for the treatment of Pearson Syndrome, a rare and life-threatening mitochondrial disorder.
MNV-201 uses the company’s proprietary Mitochondrial Augmentation Technology to deliver healthy mitochondria into a patient’s stem cells, with the aim of restoring cellular energy production and improving multi-organ function. The therapy is currently being evaluated in phase 2 clinical trials and has shown a favorable safety profile and early signs of benefit in growth, muscle strength, and hematologic stability.
On June 25, 2025, the FDA announced forthcoming labeling changes for all extended-release stimulant medications used to treat attention-deficit/hyperactivity disorder (ADHD), adding warnings about increased risks of adverse events—particularly weight loss—in children under 6 years of age.
Although these medications are not FDA-approved for use in this age group, they are sometimes prescribed off label. Based on clinical trial data, the FDA found that younger children receiving extended-release amphetamine or methylphenidate had higher drug exposure and a greater risk of clinically significant weight loss—defined as a ≥10% drop in CDC weight percentile—compared to older children.
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 monthly 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
Data published data in JAMA revealed that while overall pediatric mental health hospitalizations declined for the first time since 2009, hospitalizations among female youth continued to rise. The findings are based on a cross-sectional analysis of the 2022 Kids’ Inpatient Database, examining trends in hospitalizations for mental health and suicide/self-harm among children aged 3 to 17 years.
On June 27, 2025, the FDA updated the prescribing information for the IBAT inhibitors maralixibat (Livmarli) and odevixibat (Bylvay), adding new safety warnings related to hepatotoxicity and bleeding risks. The updates include a new contraindication for patients with prior or active hepatic events and emphasize bleeding risks tied to fat-soluble vitamin deficiency.
The changes stem from clinical trial data and postmarket reports that highlighted severe hepatic complications such as variceal hemorrhage and hepatic encephalopathy. The updated labels include recommendations for liver monitoring and criteria for treatment discontinuation.
