The sBLA includes data from the phase 3 INHALE-1 study, which showed Afrezza noninferior to MDI insulin. A PDUFA date is set for May 29, 2026.
The approval of roflumilast 0.05% provides a steroid-free, once-daily treatment option for safe and effective long-term management of pediatric eczema.
Measles vaccine coverage must reach 93% to maintain herd immunity but in 1 postelimination outbreak, the level reached only 80% in school-aged children.
The FDA has approved guselkumab for children aged 6 years and older with moderate to severe plaque psoriasis or active psoriatic arthritis, making it the first IL-23 inhibitor authorized for pediatric use.
The FDA has initiated approval of leucovorin calcium tablets for children with cerebral folate deficiency, which can manifest with autistic features. What is it?
Corticosteroids following resolution of anaphylaxis should be chosen with clear, clinical rationale and reserved for select children, study authors concluded.
Incyte announced the agency's decision, which was based on findings of significant reduction in atopic dermatitis signs and symptoms during the TRuE-AD3 clinical trial.
EADV 2025: New phase 3 data reveal delgocitinib cream's efficacy for chronic hand eczema in adolescents, confirming its safety profile in adults.
In children aged 10 to
Most parents support childhood vaccines such as MMR and polio, but skepticism about seasonal and newer shots persists, along with distrust of federal agencies.