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.
Water-related activities were the most commonly reported setting for recent sunburn, while more than one-half of respondents reported sunscreen use at the time of their most recent sunburn.
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.