The FDA approved a new subcutaneous formulation of Merck’s blockbuster cancer drug Keytruda, aiming to maintain its competitive edge against emerging biosimilars. This approval represents a strategic move to simplify administration and enhance patient compliance with immunotherapy for various cancers. The EMA's Committee for Medicinal Products for Human Use (CHMP) also recommended the subcutaneous formulation, signaling broad regulatory acceptance. This development highlights ongoing efforts to optimize delivery of leading oncology therapies during patent-protection sunsets.