KalVista Pharmaceuticals received FDA approval for Ekterly (sebetralstat), an orally-delivered treatment for hereditary angioedema (HAE), marking a significant entry on the rare disease market. Despite a delayed PDUFA date due to FDA workload, the approval was granted without safety or efficacy concerns. Meanwhile, the FDA faces internal challenges with a staff exodus and low morale attributed to political interference and resource cuts, raising regulatory capacity concerns. This juxtaposition highlights both innovation and operational pressures within the agency.