A randomized clinical trial found that a team-based connected health model achieved equivalent improvements in atopic dermatitis severity and symptoms compared with conventional in-person care over 12 months.
The expanded indication is supported by pharmacokinetic, safety, tolerability, exploratory efficacy, and long-term safety data from studies in children aged 2 to 5 years.
Approval expands risankizumab use to pediatric plaque psoriasis and psoriatic arthritis and includes a new 55-mg prefilled syringe for weight-based dosing in patients weighing less than 40 kg.
Federal prosecutors allege that a Florida physician and research staff fabricated clinical trial records that were submitted into database systems used to evaluate investigational drugs.
The sunscreen ingredient, which has been marketed internationally for years, is considered generally recognized as safe and effective for use in adults and pediatric patients aged 6 months and older.
Analyses by treatment timing, cumulative dose, and stunting supported the overall finding, though early-initiation and female subgroup data were limited.