The gadopiclenol extension for use in infants and neonates offers high-quality MRI contrast enhancement at half the standard gadolinium dose. The FDA has approved an extension of intravenous ...
Nontargeted testing identified 42 PFAS in cord blood, far exceeding the 8 compounds measured by traditional targeted methods, suggesting broader prenatal exposure. Cumulative exposure estimates ...
Phase 2 data suggest FcRn blockade may reduce maternal IgG and placental antibody transfer in HDFN without excess infant infections. Hemolytic disease of the fetus and newborn (HDFN) remains a serious ...
Wondering how to counsel parents on keeping their child’s immune system healthy through nutrition? Check out these clinical pearls from Colleen Sloan, PPA-C, RDN.
CRL focused on usability, not efficacy or manufacturing: The FDA’s Complete Response Letter for Anaphylm cited deficiencies limited to human factors, labeling, and a single supportive PK study; no CMC ...
Roflumilast cream 0.05% was well tolerated in infants aged 3 months to <24 months, with no serious adverse events and only one treatment discontinuation in the Phase 2 INTEGUMENT-INFANT study.
AbbVie submitted FDA and EMA applications seeking approval of upadacitinib (RINVOQ) 15 mg once daily for adults and adolescents aged 12 years and older with non-segmental vitiligo. Phase 3 Viti-Up ...
Experts flag missing pediatric guidance in the 2025–2030 Dietary Guidelines, including infant safety, iron intake, and early nutrition education. In episode 5 of this Special Report, Colleen Sloan, PA ...
Expanded population under review: The FDA granted priority review to marstacimab for patients 6 years and older with hemophilia A or B with inhibitors and for children aged 6 to 11 years without ...
Pediatric respiratory infection patterns and seasonality shifted significantly after the COVID-19 pandemic, reflecting disrupted and then restored pathogen transmission. Mycoplasma pneumoniae and ...