REGENERON PHARMACEUTICALS, INC: Biologic license for PASATRU
REGENERON PHARMACEUTICALS, INC: Biologic license for PASATRU. Dated 78 days ago, it serves as a historical benchmark. Score 55/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 7 published fields of this record are shown below. Locked: 499 related FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | REGENERON PHARMACEUTICALS, INC |
| Product | PASATRU |
| Generic / ingredient | GARETOSMAB-GRTS |
| Approval | Biologic license (BLA) |
| Application | BLA761508 |
| Decided | 2026-08-19 |
| Panel / class | INJECTABLE, INTRAVENOUS |
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CSV columns: Sponsor · Product · Approval · Decided · official source URL
- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-08-19
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
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55 / 100 Score
- A new product launch.
What is the FdaApprovalPulse record for REGENERON PHARMACEUTICALS, INC?
The FDA approved PASATRU (BLA761508) for REGENERON PHARMACEUTICALS, INC on 2026-08-19: biologic license (BLA).
How does REGENERON PHARMACEUTICALS, INC compare to other FdaApprovalPulse records?
It is 78 days old; check the official source for later updates before acting.
REGENERON PHARMACEUTICALS, INC vs. top 3 peers
| Organization | Record date |
|---|---|
| REGENERON PHARMACEUTICALS, INC | 2026-08-19 |
| AMGEN INC | 2026-10-22 |
| SANDOZ INC | 2026-10-22 |
| TEVA PHARMACEUTICALS, INC. | 2026-09-25 |
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FdaApprovalPulse: Biologic license (BLA)
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From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.