Has ASTELLAS had other FDA enforcement actions?

This is the only FDA action Argus HQ has on file for ASTELLAS as of 2026-07-15. Argus ingests new FDA enforcement records daily.

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

ASTELLAS — BLA approval: PADCEV (unspecified)

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

Event date: 2026-07-10 00:00:00Z
Observed: 2026-07-15 04:30:20Z
Source ID: BLA761137-37
Payload hash: fb0ff9239b1cd7405d8be3dc…

Summary

ASTELLAS received a priority supplemental BLA approval for PADCEV (unspecified) on 2026-07-10. Dosage form: INJECTABLE. Application #: BLA761137.

Entities

ASTELLAS

View source record ↗

Frequently asked questions

Has ASTELLAS had other FDA enforcement actions?: This is the only FDA action Argus HQ has on file for ASTELLAS as of 2026-07-15. Argus ingests new FDA enforcement records daily.
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). ASTELLAS — BLA approval: PADCEV (unspecified). Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-approval-astellas-bla761137-37

MLA

"ASTELLAS — BLA approval: PADCEV (unspecified)." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/events/fda-approval-astellas-bla761137-37.

Chicago

Argus HQ Research. "ASTELLAS — BLA approval: PADCEV (unspecified)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/events/fda-approval-astellas-bla761137-37.

BibTeX

@misc{argushq_argushq_ai_events_fda_approval_astellas_bla761137_37_2026,
  title = {ASTELLAS — BLA approval: PADCEV (unspecified)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-approval-astellas-bla761137-37},
  note = {Accessed: July 15, 2026}
}

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