Brian Vickery, MD, discusses a phase 1 trial evaluating the safety and tolerability of a microneedle stamp designed to deliver peanut protein through the skin.
|Articles|June 17, 2022
Must-read news from the week of June 13
Author(s)Katie Hobbins
A look at what the Contemporary Pediatrics® team covered this week.
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This week’s top articles:
The FDA today announces the EUA of both Moderna and Pfizer-BioNTech COVID-19 vaccines for use in children aged 6 months and older.
Ahead of the US Senate Judiciary Committee hearing on gun violence prevention, the American Academy of Pediatrics announced the submission of a statement including more than 300 pediatricians sharing their personal testimonies on the subject.
Data from a recent study of once weekly somapacitan injection shows positive results for prepubertal children with growth hormone deficiency (GHD).
The FDA recently announced the acceptance of a supplemental New Drug Application for relugolix 40 mg, estradiol 1 mg, and norethindrone acetate .5 mg in the treatment of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
More articles from this week:
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The FDA approved tiratricol (Emcitate) for peripheral thyrotoxicosis in MCT8 deficiency, the first approved therapy for the rare disorder.
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.
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Trending on Contemporary Pediatrics
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FDA grants priority review to leniolisib sNDA for lower-weight children with APDS
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FDA approves zilurgisertib for fibrodysplasia ossificans progressiva in patients aged 12 years and older
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FDA approves obinutuzumab to reduce relapse risk in childhood-onset idiopathic nephrotic syndrome
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First-in-human trial tests microneedle stamp approach for peanut allergy
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