Arcutis submits roflumilast 0.15% sNDA for AD in children 6 years and up
September 21st 2023Positive topline results from a pair of identical phase 3 trials support the submission of a supplemental New Drug Application to the FDA for Arcutis Biotherapeutics’ roflumilast cream 0.15%, a once-daily topical to treat mild to moderate atopic dermatitis (AD) in children 6 years or older.
Roflumilast cream 0.05% safe, effective for children aged 2 to 5 years with atopic dermatitis
September 20th 2023Based on recent positive phase 3 results, Arcutis Biotherapeutics,. intends to submit a supplemental New Drug Application with the FDA for roflumilast cream 0.05% to treat mild to moderate atopic dermatitis in children aged 2 to 5 years.
FDA issues CRL for neffy nasal spray to treat allergic reactions, requests more research
September 20th 2023The FDA issued the Complete Response Letter (CRL) based on the request for a completed pharmacokinetic/pharmacodynamic study to assess how repeat doses of the epinephrine nasal spray compare to repeat doses of an epinephrine injection product. ARS Pharma is set to file a Formal Dispute Resolution Request to appeal the CRL.
Associations between prenatal metal mixture exposure and negative infant outcomes
September 19th 2023Francheska M. Merced-Nieves, PhD, Assistant professor, Departments of Pediatrics and the Institute for Exposomic Research of Environmental Medicine & Public Health, Icahn School of Medicine at Mount Sinai, explains the associations prenatal exposure to a metal mixture and the potential negative effects for the infant.
Poll: Majority of parents concerned about bad air quality, impact on child's health
September 19th 2023According to a recent C.S. Mott Children’s Hospital National Poll on Children’s Health, the recent wildfires and extreme weather events that are creating poor or unhealthy air quality are also causing concern for parents in regards to their children's health.
Study: Pediatric type 1 diabetes families prefer virtual care and telehealth
September 14th 2023Surveys collected for a study published in the Canadian Journal of Diabetes revealed that desire for telehealth care amid pediatric diabetes families increased from the early onset of the COVID-19 pandemic, to more than 1 year later.
The current state of transgender reproductive care in the United States
September 14th 2023In this interview originally conducted by our sister publication Contemporary OB/GYN, Marci Bowers, MD, shares the biggest takeaways from her presentation on transgender reproductive care, presented at the 2023 Society of OB/GYN Hospitalists Annual Clinical Meeting in Chicago, Illinois.
Developing biomarkers for gut and neurological, cognitive functioning associations in children
September 7th 2023In this Contemporary Pediatrics interview, Rob Knight, PhD, discusses translating adult studies into children to determine gut microbiome biomarkers, and how they are associated with neurological and cognitive conditions.