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Merck Says US FDA Approves Keytruda Qlex Subcutaneous Injection
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Merck Says US FDA Approves Keytruda Qlex Subcutaneous Injection
Sep 22, 2025 4:21 AM

06:51 AM EDT, 09/22/2025 (MT Newswires) -- Merck ( MRK ) said Monday the US Food and Drug Administration has approved Keytruda Qlex subcutaneous injection for treating adults with solid tumors.

The company said the injection is approved for 38 indications and can be administered in one minute every three weeks or two minutes every six weeks.

The drugmaker said the approval was based on a phase 3 trial showing comparable efficacy and safety to intravenous Keytruda.

Keytruda Qlex is expected to be available in the US from late September, the company said.

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