Weekly review: Centanafadine NDA, gene therapy approval, and more

Thank you for visiting the Contemporary Pediatrics® website. Take a look at some of our top stories from last week (Monday, November 24, to Friday, November 28, 2025), and click on each link to read and watch anything you may have missed.

Otsuka submits centanafadine NDA to FDA to treat ADHD in children, adolescents, adults

On November 25, 2025, Otsuka Pharmaceutical submitted a new drug application (NDA) to the FDA for centanafadine (CTN), an investigational once-daily norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) for treating ADHD in children, adolescents, and adults. The submission is supported by four phase 3 trials demonstrating statistically significant and clinically meaningful improvements in ADHD symptoms versus placebo, measured by the ADHD Rating Scale-5 (ADHD-RS-5).

Click here for the full article.

FDA approves first gene replacement therapy (Itvisma) for patients 2 years and older with spinal muscular atrophy

On November 24, 2025, the FDA approved Itvisma (onasemnogene abeparvovec-brve; Novartis) for children aged 2 years and older, adolescents, and adults with spinal muscular atrophy (SMA) who have a confirmed SMN1 mutation. Itvisma is the first gene replacement therapy authorized for this population and is administered as a single intrathecal dose, designed to provide a functional SMN1 gene and support sustained motor function.

Click here for the full article.

The safety and tolerability of tapinarof cream 1%

Druhan Howell, MD, allergist-immunologist, Mobile, Alabama, and Organon Health Partner, discussed safety and tolerability recently reported for Organon's tapinarof cream 1% (VTAMA) for pediatric atopic dermatitis. Safety and tolerability findings were consistent with previously reported ADORING data, with no new safety signals identified in the pooled analysis.

To watch the full interview with Howell and for more on tapinarof cream 1%, click here.

Eye spy: A case of a corneal lesion in an 8-year-old girl

The Case

An 8-year-old previously healthy female presents to the pediatrician’s office to establish care after recently moving to the United States from Peru 3 months ago. Past medical history is significant for mild intermittent asthma. Past surgical history is significant for the removal of left-sided preaxial polydactyly as well as the removal of right-sided preauricular appendage while living in Peru. Patient is not currently taking medications and is otherwise healthy. Immunizations are up to date. Physical exam is notable for a tan colored lesion on the left eye that Mom states has been present since birth. Mom reports that they saw an eye doctor in Peru who would not remove the lesion due to its proximity to the pupil. Mom reports no significant change in the size of the lesion since onset. The child is not bothered by the lesion and can close eyelids without difficulty.

What's the diagnosis?

Click here for the full case presentation.

FDA grants 510(k) clearance for Clarity algorithm to detect electrographic seizures in newborns

On November 24, 2025, the FDA granted 510(k) clearance to CeriBell Inc. for its Clarity algorithm, the first AI-powered point-of-care EEG technology capable of detecting electrographic seizures in patients from newborns through adults. The system uses real-time analysis to support rapid bedside neurological assessment, addressing critical gaps in seizure detection, particularly in neonatal intensive care units where continuous EEG monitoring is often limited.

Click here for the full article.