The approval was based on reduced proteinuria, and an ongoing trial is required to determine whether atacicept slows long-term kidney function decline.
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The agency outlined early regulatory actions supporting nonanimal methods, including draft guidance, artificial intelligence tools, and expanded use of human-relevant data models.