Higher preconception maternal and paternal vitamin B12 was tied to fewer birth defects in a Shanghai cohort of 3032 couples.
|Articles|October 1, 2012
Warning on SimplyThick now includes infants of any age
The US Food and Drug Administration (FDA) cautions that SimplyThick, a brand of thickening agent added to breast milk or formula for premature babies, has been linked to necrotizing enterocolitis (NEC) in a full-term infant.
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The FDA has approved Tivicay PD (dolutegravir) to treat HIV-1 in newborns from birth, based on IMPAACT 2023 pharmacokinetic and safety data.
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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FDA grants priority review to leniolisib sNDA for lower-weight children with APDS
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FDA approves baricitinib for adolescents with severe alopecia areata
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FDA approves zilurgisertib for fibrodysplasia ossificans progressiva in patients aged 12 years and older
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Starting HPV vaccination earlier gives pediatricians more opportunities to protect children
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