What is the FDA application number for this submission?

FDA application number BLA125514, submission 192.

What review priority did FDA assign?

FDA designated this submission as: PRIORITY.

What dosage form is KEYTRUDA?

KEYTRUDA is formulated as: SOLUTION.

What did FDA approve?

FDA's record shows BLA approval for KEYTRUDA (Not disclosed in the FDA record.), dosage form SOLUTION, sponsored by MERCK SHARP DOHME, under application number BLA125514. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway.

FDA Approves KEYTRUDA — SUPPL Submission by MERCK SHARP DOHME, Not disclosed in the FDA record.

Key facts

Sponsor	MERCK SHARP DOHME
Brand name	KEYTRUDA
Generic name	unspecified
Dosage form	SOLUTION
Application number	BLA125514
Submission number	192
Submission type	SUPPL
Review priority	PRIORITY
Status date	Not disclosed in the FDA record.

Key takeaway: MERCK SHARP DOHME received BLA approval for KEYTRUDA (Not disclosed in the FDA record.) on 2026-06-12. Application number BLA125514, submission type SUPPL (submission 192). Dosage form: SOLUTION. 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.

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, with the generic name recorded as Not disclosed in the FDA record. and dosage form SOLUTION. 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 192) under application number BLA125514, 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 is the FDA application number for this submission?: FDA application number BLA125514, submission 192.
What review priority did FDA assign?: FDA designated this submission as: PRIORITY.
What dosage form is KEYTRUDA?: KEYTRUDA is formulated as: SOLUTION.
What did FDA approve?: FDA's record shows BLA approval for KEYTRUDA (Not disclosed in the FDA record.), dosage form SOLUTION, sponsored by MERCK SHARP DOHME, under application number BLA125514. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway.

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Full FDA history for MERCK SHARP DOHME

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Approves KEYTRUDA — SUPPL Submission by MERCK SHARP DOHME, Not disclosed in the FDA record.. Digital Empire LLC. Retrieved from https://argushq.ai/approval/fda-approval-merck-sharp-dohme-bla125514-192

MLA

"FDA Approves KEYTRUDA — SUPPL Submission by MERCK SHARP DOHME, Not disclosed in the FDA record.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/approval/fda-approval-merck-sharp-dohme-bla125514-192.

Chicago

Argus HQ Research. "FDA Approves KEYTRUDA — SUPPL Submission by MERCK SHARP DOHME, Not disclosed in the FDA record.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/approval/fda-approval-merck-sharp-dohme-bla125514-192.

BibTeX

@misc{argushq_argushq_ai_approval_fda_approval_merck_sharp_dohme_bla125514_192_2026,
  title = {FDA Approves KEYTRUDA — SUPPL Submission by MERCK SHARP DOHME, Not disclosed in the FDA record.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/approval/fda-approval-merck-sharp-dohme-bla125514-192},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Approvals ↗