Contemporary Pediatrics

ICYMI: An FDA decision on the supplemental New Drug Application (sNDA) for roflumilast cream 0.15%—to treat mild to moderate atopic dermatitis (AD) in adults and children down to 6 years of age—has yet to come despite the passing of the July 7, 2024, Prescription Drug User Fee Act (PDUFA) date. More details as Arcutis awaits FDA action: https://lnkd.in/ejV7Br2H

🚨BREAKING NEWS🚨: Roflumilast cream 0.15% (ZORYVE; Arcutis Biotherapeutics) has been approved by the FDA to treat mild to moderate #atopicdermatitis in adults and children aged 6 years and older. https://lnkd.in/eg6nvmYV

More #FDA news: Mesoblast Limited has resubmitted a BLA for remestemcel-L (Ryoncil) as a potential treatment for children with steroid-refractory acute graft versus host disease (SR-aGVHD). The resubmission is expected to have a review period of between 2 and 6 months from receipt. MORE: https://lnkd.in/eabqWyvA

On July 1, 2024, the FDA approved biosimilar ustekinumab-ttwe (Pyzchiva; Samsung Bioepis) for all indications of its reference medicine, ustekinumab (Stelara; Johnson & Johnson), including the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in patients aged 6 years and older. MORE: https://lnkd.in/e_UNtfpY

Updated: An FDA decision on the supplemental New Drug Application (sNDA) for roflumilast cream 0.15%—to treat mild to moderate atopic dermatitis (AD) in adults and children down to 6 years of age—has yet to come despite the passing of the July 7, 2024, Prescription Drug User Fee Act (PDUFA) date. More details as Arcutis awaits FDA action: https://lnkd.in/ejV7Br2H

#FDA news this morning: Arcutis Biotherapeutics is still waiting on a decision from the FDA regarding roflumilast cream 0.15% to treat atopic dermatitis in children 6 years and older, releasing the following statement this morning. Keep in touch with Contemporary Pediatrics for updates and latest news.

Welcome to a new week! Get caught up with our journal, with this weekly review! Click the link below and easily review our top articles from the last week, with an option to further read each one. Our top stories include: - A new puzzler case to diagnose - Social media & impact on mental health - A traditional FDA approval for pulmonary tuberculosis Read here: https://lnkd.in/eXK5bd82

At the link below, read the digital version of the July issue of Contemporary Pediatrics, with a focus on water safety! A note from our editorial advisory board member, Donna Hallas, PhD, RN, PPCNP-BC, CPNP, PMHS, FAANP, FAAN: Read our July issue: https://lnkd.in/eWswKg_Y

Our latest Journal Club with Jon Matthew Farber, MD, highlights PUFAs and #ADHD. Click here to read the full article: https://lnkd.in/e9c9ngyd

Welcome to a new week! Get caught up with our journal, with this weekly review! Click the link below and easily review our top articles from the last week, with an option to further read each one. Our top stories include: - A new puzzler case to diagnose - Social media & impact on mental health - A traditional FDA approval for pulmonary tuberculosis Read here: https://lnkd.in/eXK5bd82