Johnson&Johnson announced on the 23rd that the US FDA has approved its Opsynvi monotherapy combination therapy for long-term treatment of adult patients with pulmonary arterial hypertension (PAH) classified as II-III by the World Health Organization (WHO) Functional Classification (FC). The approval of Opsynvi enables Johnson&Johnson's PAH product portfolio to cover all PAH targeted pathways recommended by the guidelines. It is reported that Opsynvi is the first FDA approved PAH single tablet combination therapy. The approval of Opsynvi by the US FDA is mainly based on the results of key Phase 3 clinical studies of A DUE, in which Opsynvi demonstrates that patients have a greater reduction in pulmonary vascular resistance (PVR) after 16 weeks of treatment compared to monotherapy with tadalafil or macitabine.