Bookshelf

FDA accepts leniolisib sNDA with priority review for children with APDS aged 4+ weighing 13 to <27 kg; PDUFA date is January 30, 2027.

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.