Identifying benign lesions in female patients by new algorithm
October 6th 2023In this Q+A interview originally conducted by our sister publication, Contemporary OB/GYN, Peter Minneci, MD, MHSc, discusses a study evaluating a new algorithm capable of accurately identifying benign lesions in female patients.
Nedosiran injection FDA-approved for children with primary hyperoxaluria type 1
October 5th 2023The approval of the prescription injection for children aged 9 years and up is based on data from a phase 2 and an ongoing phase 3 trial extension study, that demonstrated the lowering of urinary oxalate levels for individuals with primary hyperoxaluria type 1 (PH1).
FDA issues health care provider letter for probiotics in preterm infants
October 4th 2023The FDA has issued a Dear Healthcare Provider Letter highlighting information about the use of probiotics in preterm infants and the risk for potentially fatal disease caused by bacteria or fungi contained in these products.
Updated Novavax COVID-19 vaccine authorized for individuals 12 years and up
October 4th 2023Individuals 12 years and older can now receive the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) to protect against variants that are currently circulating, after receiving an Emergency Use Authorization from the FDA.
Toxicity related to THC dose in pediatric edible cannabis ingestions
October 3rd 2023The degree of toxicity following pediatric ingestion of THC was correlated to the dose of THC, as ingestions of 1.7 mg/kg or more were predictive of severe and prolonged toxicity, according to a study published in Pediatrics.
Comparing body composition of preterm infants on human breast milk or cow milk diet
October 3rd 2023Through a randomized, multicenter, open-label, controlled study, investigators determined there were no suggestions of important differences for very preterm infant body composition when comparing an exclusive human milk diet to a diet containing cow milk products.
FDA approves tocilizumab-bavi as biosimilar for PJIA, SJIA in children 2 years and up
October 2nd 2023Tocilizumab-bavi (Tofidence; Biogen) demonstrated a biosimilarity to tocilizumab (Actemra; Genentech) based on multifaceted clinical and non-clinical data for polyarticular juvenile idiopathic arthritis (PJIA) and systemic juvenile idiopathic arthritis (sJIA) in children aged 2 years and up. This makes it the first tocilizumab biosimilar to be FDA-approved in the United States, according to Biogen.
Will FDA approved phentolamine ophthalmic solution 0.75% eye drops impact pediatric care?
September 28th 2023In this Contemporary Pediatrics® interview, Rupa Wong, MD, discusses the recent FDA approval of phentolamine ophthalmic solution 0.75% eye drops to treat pharmacologically-induced mydriasis, and how this could impact the treatment landscape for the pediatric population. [Editor's note: RYZUMVI was previously known as Nyxol, which is referenced in the interview.]
Discussing the upcoming RSV season, new tools, and vaccine hesitancy
September 27th 2023In collaboration with Contemporary Pediatrics, Contemporary OB/GYN, and Contagion, Tina Tan, MD, FAAP, FIDSA, FPIDS, discusses the benefits of having new tools to fight RSV in infants, potential vaccine hesitancy, and RSV trends currently being observed.
Evaluating pediatric ED readiness and racial, ethnic disparities in mortality
September 27th 2023Peter C. Jenkins, MD, MSc, details his study recently published in Jama Network Open, evaluating associations between pediatric emergency department readiness and mortality, and if children of all races benefited equitably.
CDC recommends Pfizer’s maternal RSV vaccine to protect newborns
September 25th 2023Ahead of the first fall and winter virus seasons in which vaccines are available for COVID-19, influenza, and respiratory syncytial virus (RSV), the Centers for Disease Control and Prevention is recommending Pfizer’s maternal vaccine to protect newborns from severe RSV illness.
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.