The 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).
A new nonprofit organization is hoping to limit financial restrictions when it comes to pediatric mental health care.
The 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.
Individuals 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.
The 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.
Through 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.
The 20 children in the investigation had been diagnosed with ASD by PCPs who were trained using the ECHO (Extension for Community Healthcare Outcomes) Autism Screening Tool for Autism in Toddlers and Young Children (STAT).
*Co-first authorship was earned, as each equally contributed to the methodical and rigorous review of the literature, writing, and editing of this article.
Tocilizumab-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.
Review some of the top stories from the Contemporary Pediatrics website over the last week, and catch up on anything you may have missed.
An increased risk of cerebral palsy was observed in children conceived in the winter and spring compared to summer, according to a recent study published in JAMA Network Open.
Fitness benefits of additional after-school physical activity were observed for school children in China compared to choice of activity, while academic performance was not compromised according to a recently published study in JAMA Pediatrics.
In 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.]
Results from the phase 3 MIRA-4 pediatric trial demonstrated a favorable safety and tolerability profile with no reported adverse events. Rupa Wong, MD, offers thoughts on the approval, and why it may not change day-to-day practice when it comes to the pediatric population.
In 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.
Peter 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.
James Wallace, MD, explains the various negative effects associated with school avoidance and how primary health care providers, along with parents, can catch early signs of social and separation anxiety.
The number of children who received a T1D diagnosis did not differ from children with and without SARS-CoV-2 infection.
Data from a 4-year trial of preschool-aged children offers new insight into the effects of initiating obesity management strategies among children in early life.
Donna Hallas, PhD, PPCNP-BC, CPNP, PMHS, FAANP, FAAN, shares her thoughts on the latest issue of Contemporary Pediatrics, including her concern with using ChatGPT for medical information and decisions.
Ahead 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.
Review some of the top stories from the Contemporary Pediatrics website over the last week, and catch up on anything you may have missed.
In a recent study, women with a history of dysmenorrhea were at a significantly increased risk of endometriosis.
In a recent study, increased rates of precocious puberty were observed during the COVID-19 pandemic compared to prior years.
In this Contemporary Pediatrics interview, James Wallace, MD, discusses increased trends in school avoidance and the negative effects associated with less days in the classroom.
Positive 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.
Based 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.
The 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.
Francheska 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.
In a recent study, the 2013 WHO criteria for diagnosing gestational diabetes mellitus had a low sensitivity when used in individuals in low-risk early pregnancy.
