FDA accepts leniolisib sNDA with priority review for children with APDS aged 4+ weighing 13 to <27 kg; PDUFA date is January 30, 2027.
|Articles|February 3, 2023
Free continuing education credits
Author(s)Children's Hospital of Philadelphia
Advertisement
On March 15, 2023, Dr. Paul Offit, Director of the VEC, discussed “The Future of COVID-19 Vaccines.” Free continuing education credits (CME, CEU, CPE) are available thanks to support from the Thomas F. McNair Scott Endowed Research and Lectureship Fund. The Vaccine Education Center (VEC) at Children’s Hospital of Philadelphia would also like to thank our co-sponsors, the Pennsylvania chapter of the American Academy of Pediatrics and Nesbitt School of Pharmacy at Wilkes University.
Advertisement
Related to this article
FDA approves oral ALK2 inhibitor zilurgisertib for FOP in patients 12+, based on phase 2 PROGRESS data on new heterotopic ossification volume.
The approval is based on BRAVE-AA-PEDS, in which 42% of adolescents receiving baricitinib 4 mg achieved at least 80% scalp hair coverage at week 36 vs 5% with placebo.
FDA approved obinutuzumab for relapsing or steroid-dependent childhood-onset INS, based on INShore data showing 95.5% vs 73.2% sustained remission.
Review some of the top stories from the Contemporary Pediatrics website over the last week, and catch up on anything you may have missed.
Glucommander Pediatrics received FDA Breakthrough Device Designation for IV insulin dosing in hospitalized children younger than 2 years, but remains uncleared.
Jonathan Miller, MD, discusses earlier HPV vaccination, individualized conversations with hesitant families, and strategies to improve vaccine uptake.
Jonathan Miller, MD, discusses factors behind lagging HPV vaccination rates and how pediatricians can address common parent concerns.
Advertisement
Advertisement
Trending on Contemporary Pediatrics
1
FDA approves baricitinib for adolescents with severe alopecia areata
2
FDA approves zilurgisertib for fibrodysplasia ossificans progressiva in patients aged 12 years and older
3
FDA grants priority review to leniolisib sNDA for lower-weight children with APDS
4
Starting HPV vaccination earlier gives pediatricians more opportunities to protect children
5