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 January 2026 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 November and easily stay in touch with our digital newsletters that bring you practical information for today's pediatrician.

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

FDA updates in pediatric care: January 2026

1. FDA approves caplacizumab for pediatric acquired thrombotic thrombocytopenic purpura

On January 5, 2026, the FDA approved caplacizumab (Cablivi; Sanofi) for the treatment of pediatric patients aged 12 years and older with acquired thrombotic thrombocytopenic purpura, to be used in combination with plasma exchange and immunosuppressive therapy. The expanded indication was supported by retrospective pediatric data showing an 80% clinical remission rate, defined by sustained platelet normalization and biochemical recovery, and aligns pediatric management with established adult treatment paradigms for this rare, life-threatening thrombotic microangiopathy.

2. FDA approves Zycubo for treatment of Menkes disease in children

On January 12, 2025, the FDA approved Zycubo (copper histidinate; Sentynl Therapeutics) for the management of Menkes disease in children, marking the first FDA-approved therapy for this ultra-rare, life-threatening neurodegenerative disorder. The decision was supported by data from 2 open-label, single-arm clinical trials showing a 78% reduction in mortality compared with untreated patients, with markedly improved long-term survival, including survival beyond 6 years in nearly half of treated children. The approval introduces a subcutaneous copper replacement therapy that bypasses defective intestinal absorption, offering a disease-modifying option for a condition historically associated with death in early childhood.

3. FDA clears expanded pediatric use of robotic-assisted cochlear implant insertion system

On January 14, 2026, the FDA granted 510(k) clearance for expanded pediatric use of the iotaSOFT Insertion System (iotaMotion), allowing use in children aged 4 years and older undergoing cochlear implant surgery. The robotic-assisted system is designed to standardize electrode array insertion—a critical step associated with risk of intracochlear trauma and loss of residual hearing—and is the first FDA-cleared technology of its kind. The expanded clearance was supported by preclinical and clinical evidence showing reduced insertion-related trauma and higher rates of hearing preservation compared with manual techniques, positioning iotaSOFT as a potential tool to support safer, more consistent cochlear implantation in pediatric patients.

4. FDA clears first at-home test to detect RSV, influenza, and COVID-19 in infants as young as 6 months

On January 23, 2026, the FDA cleared the Flowflex Plus RSV + Flu A/B + COVID 4-in-1 Home Test (ACON Laboratories), the first at-home diagnostic authorized to detect respiratory syncytial virus, influenza A, influenza B, and SARS-CoV-2 in adults and children as young as 6 months. The over-the-counter rapid antigen test uses a single nasal swab and provides results within minutes, enabling earlier differentiation of common respiratory infections that often present with similar symptoms. The clearance marks the first FDA-authorized home RSV test for infants, expanding access to at-home respiratory testing and supporting more timely decision-making for families during peak viral seasons.

5. FDA accepts centanafadine NDA for priority review for ADHD in children, adolescents

On January 27, 2026, the FDA accepted the New Drug Application for centanafadine (Otsuka Pharmaceutical) for priority review as a potential treatment for attention-deficit/hyperactivity disorder in children, adolescents, and adults, with a PDUFA target action date of July 24, 2026. The investigational once-daily extended-release agent is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor, supported by 4 phase 3 trials demonstrating significant improvements in ADHD symptoms across pediatric, adolescent, and adult populations compared with placebo. If approved, centanafadine would introduce a novel nonstimulant mechanism aimed at broad symptom management in a condition with persistent unmet therapeutic needs.

6. FDA issues complete response letter for sublingual epinephrine film Anaphylm

On January 30, 2026, the FDA issued a complete response letter for Anaphylm (dibutepinephrine; Aquestive Therapeutics) Sublingual Film, a noninvasive epinephrine candidate for the treatment of type I allergic reactions, including anaphylaxis, in patients weighing 30 kg or more. The CRL cited deficiencies limited to human factors validation, labeling, and the need for a single supportive pharmacokinetic study following planned packaging modifications, with no concerns raised regarding efficacy, manufacturing, or comparability data. The company outlined a clear regulatory path forward, including updated packaging, a new human factors study, and parallel PK evaluation, with NDA resubmission anticipated in the third quarter of 2026.