GSK gained FDA approval for depemokimab (Exdensur) as an add‑on maintenance therapy for severe eosinophilic asthma in patients aged 12 and older, becoming the first biologic cleared with twice‑yearly dosing. Company data from two late‑stage trials showed reductions in exacerbations and hospitalizations versus placebo. GSK projects Exdensur could become a high‑value respiratory product due to the dosing convenience and comparable efficacy; the approval follows a CHMP positive opinion in Europe for related indications. Clinicians may weigh the dosing schedule against established competitors across IL‑5 and type‑2 inflammation targets. Regulatory and commercial follow‑up will focus on patient selection, adherence advantages tied to less frequent administration, and real‑world uptake among eligible severe asthma patients.