The FDA has recently approved several notable drugs including KalVista Pharmaceuticals' oral treatment for hereditary angioedema, Dizal Pharmaceutical’s sunvozertinib for metastatic non-small-cell lung cancer, and KalVista’s Ekterly for acute swelling attacks from rare disease HAE. However, the agency faces deepening morale and staffing crises amid political pressures and workforce reductions, raising concerns about the long-term impact on regulatory capacity. The first half of 2025 witnessed drug approvals largely consistent with previous years despite these difficulties. Industry watchers emphasize balancing regulatory thoroughness with resource challenges.