Merck received FDA clearance for a new subcutaneous formulation of Keytruda, its blockbuster cancer immunotherapy. This novel delivery method aims to improve patient convenience and maintain Merck’s competitive lead amid increasing biosimilar threats. The approval follows favorable opinions from the European CHMP, reflecting broad regulatory confidence. Subcutaneous Keytruda has promise to extend the product’s commercial lifecycle while ensuring continued patient access to this life-extending therapy.