The U.S. Food and Drug Administration (FDA) has approved a new subcutaneous formulation of Keytruda, Merck's leading cancer immunotherapy drug. The approval seeks to provide a less invasive administration option and extend Keytruda’s market life amid impending biosimilar competition. Separately, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of this formulation, marking a coordinated regulatory advancement. The subcutaneous route is intended to enhance patient convenience and optimize healthcare resource utilization in oncology settings.