The U.S. Food and Drug Administration (FDA) announced on September 19, 2025, the approval of a new formulation of Merck's blockbuster cancer therapy, Keytruda. This new version can be administered under the skin, offering a more convenient option for patients.
This approval is a critical development for Merck as it prepares for the eventual loss of exclusivity for the intravenous formulation of Keytruda. The subcutaneous version is expected to help retain market share and extend the product's lifecycle against biosimilar competition.
The new injectable Keytruda provides a significant improvement in patient convenience, potentially reducing administration time and healthcare resource utilization. This strategic approval reinforces Merck's leadership in oncology and its proactive approach to pipeline management.
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