Ecopipam lowered relapse risk in pediatric Tourette syndrome responders in phase 3 data supporting a planned FDA submission. A phase 3 trial of ecopipam (Emalex Biosciences), an investigational ...
RSV-associated lower respiratory tract infection hospitalization occurred in 0.86% of infants who received both RSVpreF exposure and nirsevimab. Most infants in the cohort received nirsevimab before ...
Learn how to spot and treat pediatric insomnia: sleep hygiene first, behavioral tools, and when melatonin or other off-label meds fit. Chronic insomnia refers to difficulty in initiating or ...
Ayman Chit is Head of Vaccines Medical, North America at Sanofi, where he leads medical strategy to advance vaccine innovation and improve public health outcomes. With expertise spanning biotechnology ...
Children with mild traumatic brain injury (mTBI) experience significantly greater rates of new-onset and chronic sleep disturbances compared with typically developing children and those with ...
The FDA has approved once-weekly somapacitan-beco for children aged 2.5 years and older with 3 separate growth indications. The FDA has approved somapacitan-beco (Sogroya; Novo Nordisk) 5 mg, 10 mg, ...
CRL focused on usability, not efficacy or manufacturing: The FDA’s Complete Response Letter for Anaphylm cited deficiencies limited to human factors, labeling, and a single supportive PK study; no CMC ...
Findings from phase 3 SHORE and COAST 2 trials showed amlitelimab met key efficacy end points in moderate to severe atopic dermatitis, supporting planned regulatory submissions. Sanofi announced ...
Katie McMahon and Kathy Baylis, PhD, discuss research showing that prenatal exposure to hot, humid conditions has significant effects on child growth and health. In a Contemporary Pediatrics video ...
FDA approves first irritable bowel syndrome with constipation (IBS-C) treatment, linaclotide (Linzess), for children aged 7 years and older based on pediatric and adult trial data. Compared with ...
The FDA has assigned a target action date of February 28, 2026, for a potential expanded indication of pegvaliase-pqpz to include adolescents with PKU. FDA Priority Review accepted for pegvaliase-pqpz ...
The FDA acknowledged that the primary endpoint was met but that "data do not support the effectiveness of low-dose atropine in children with myopia," according to Sydnexis. FDA issued a complete ...
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