MERCK SHARP DOHME — FDA SUPPL Approval for KEYTRUDA QLEX (Not disclosed in the FDA record.)

Key facts

Regulatory context

This application was reviewed under FDA's priority review pathway, granted when a product may offer a significant improvement over existing treatments, which typically targets a 6-month review goal measured from submission. A Biologics License Application (BLA) is the FDA pathway used to approve biologic products such as vaccines, blood products, and therapies derived from living organisms. A BLA requires the sponsor to submit data demonstrating the product is safe, pure, and potent for its intended use. FDA approval of an application does not itself guarantee ongoing marketing; sponsors remain subject to post-approval manufacturing inspections and adverse-event reporting requirements.

What was approved

FDA's record shows MERCK SHARP DOHME as the sponsor of KEYTRUDA QLEX, with the generic name recorded as Not disclosed in the FDA record. and dosage form INJECTABLE. A Biologics License Application (BLA) is the FDA pathway used to approve biologic products such as vaccines, blood products, and therapies derived from living organisms. A BLA requires the sponsor to submit data demonstrating the product is safe, pure, and potent for its intended use. This specific application is submission type SUPPL (submission number 9) under application number BLA761467, with a submission status date of 20260612. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission. This record is drawn directly from FDA's own approvals database rather than from company press materials. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission.

MERCK SHARP DOHME’s FDA history

Argus HQ has recorded 3 total FDA actions tied to MERCK SHARP DOHME: 0 warning letters, 0 recalls, 3 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What did FDA approve?

FDA's record shows BLA approval for KEYTRUDA QLEX (Not disclosed in the FDA record.), dosage form INJECTABLE, sponsored by MERCK SHARP DOHME, under application number BLA761467. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway.

What does the submission type mean?

A Biologics License Application (BLA) is the FDA pathway used to approve biologic products such as vaccines, blood products, and therapies derived from living organisms. A BLA requires the sponsor to submit data demonstrating the product is safe, pure, and potent for its intended use.

Is this product available now?

FDA's record lists a submission status date of 20260612. Availability, pricing, and distribution details beyond the submission status date are Not disclosed in the FDA record. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway.

Does MERCK SHARP DOHME have other FDA approval records?

Yes. Argus HQ has recorded 3 total FDA actions tied to MERCK SHARP DOHME, including 3 approval records.

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