After a delay attributed to FDA workload constraints, KalVista Pharmaceuticals received FDA approval for Ekterly (sebetralstat), the first oral on-demand treatment for hereditary angioedema (HAE) attacks in patients aged 12 and older. The approval was based on robust phase 3 trial data demonstrating rapid and sustained symptom relief. This approval introduces an oral alternative to existing injectable therapies, potentially reshaping the HAE treatment landscape and market dynamics.