REGULATORY

Japan Panel Clears KalVista’s HAE Drug, GSK’s Asthma Agent, and More for Approval

November 28, 2025
A Japanese health ministry panel on November 27 endorsed approvals for seven new molecular entities (NMEs) — including KalVista Pharmaceuticals’ on-demand hereditary angioedema (HAE) therapy sebetralstat, known overseas as Ekterly. The Pharmaceutical Affairs Council’s Second Committee on Drugs backed sebetralstat,…

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