Exagamglogene autotemcel is now indicated for patients aged 2 years and older with sickle cell disease and recurrent vaso-occlusive crises or transfusion-dependent beta thalassemia.
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.
Updated 2025-2026 vaccination was linked to added protection in a CDC-funded analysis that became part of a broader debate over routine vaccine monitoring.
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A structured overview of recent FDA recalls, corrections, and alerts involving medications, ventilators, insulin delivery systems, cardiovascular devices, anesthesia products, and other equipment used in clinical practice.