Has MERCK SHARP DOHME had other FDA enforcement actions?

Yes. Argus HQ has recorded 5 total FDA actions tied to MERCK SHARP DOHME: 0 warning letters, 0 recalls, 5 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Drug Approval, tagged info severity by Argus HQ. FDA published the underlying record on 2026-07-10; Argus observed and indexed it on 2026-07-15.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_approval · bla · info

MERCK SHARP DOHME — BLA approval: KEYTRUDA (unspecified)

Name: FDA Drug Approval Record — MERCK SHARP DOHME
Creator: Argus HQ
Published: 2026-07-10
License: https://argushq.ai/methodology

Event date: 2026-07-10 00:00:00Z
Observed: 2026-07-15 04:30:21Z
Source ID: BLA125514-194
Payload hash: 28ee9b859b126d7e88d6ed40…

Summary

MERCK SHARP DOHME received a priority supplemental BLA approval for KEYTRUDA (unspecified) on 2026-07-10. Dosage form: SOLUTION. Application #: BLA125514.

Entities

MERCK SHARP DOHME

View source record ↗

Frequently asked questions

Has MERCK SHARP DOHME had other FDA enforcement actions?: Yes. Argus HQ has recorded 5 total FDA actions tied to MERCK SHARP DOHME: 0 warning letters, 0 recalls, 5 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Drug Approval, tagged info severity by Argus HQ. FDA published the underlying record on 2026-07-10; Argus observed and indexed it on 2026-07-15.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

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). MERCK SHARP DOHME — BLA approval: KEYTRUDA (unspecified). Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-approval-merck-sharp-dohme-bla125514-194

MLA

"MERCK SHARP DOHME — BLA approval: KEYTRUDA (unspecified)." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/events/fda-approval-merck-sharp-dohme-bla125514-194.

Chicago

Argus HQ Research. "MERCK SHARP DOHME — BLA approval: KEYTRUDA (unspecified)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/events/fda-approval-merck-sharp-dohme-bla125514-194.

BibTeX

@misc{argushq_argushq_ai_events_fda_approval_merck_sharp_dohme_bla125514_194_2026,
  title = {MERCK SHARP DOHME — BLA approval: KEYTRUDA (unspecified)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-approval-merck-sharp-dohme-bla125514-194},
  note = {Accessed: July 15, 2026}
}

Informational only. Not legal, financial, or medical advice.