The FDA approved KalVista Pharmaceuticals’ sebetralstat for hereditary angioedema, representing a vital new therapeutic option for rare swelling disorders. Meanwhile, the agency faces deepening morale and staffing crises, with widespread staff departures raising concerns about regulatory capacity. Political and administrative challenges have led to talent loss and reduced trust within FDA, potentially impacting drug and device oversight. Additionally, regulatory shifts concerning U.S.-China biotechnological collaborations may affect future innovation and investment flows.