SHORLA ONCOLOGY: labeling supplement approved for IMKELDI
SHORLA ONCOLOGY: labeling supplement approved for IMKELDI. Dated 20 days ago, it is in the active follow-up window. Score 65/100. 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 | SHORLA ONCOLOGY |
| Product | IMKELDI |
| Generic / ingredient | IMATINIB MESYLATE |
| Approval | Drug labeling or REMS supplement |
| Application | NDA219097 supplement 4 |
| Decided | 2026-10-16 |
| Panel / class | SOLUTION, ORAL |
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| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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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: 2026-10-16
- 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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65 / 100 Score
- Decided in the last 30 days.
- New labeling to print and distribute.
What is the FdaApprovalPulse record for SHORLA ONCOLOGY?
The FDA approved IMKELDI (NDA219097 supplement 4) for SHORLA ONCOLOGY on 2026-10-16: drug labeling or REMS supplement.
How does SHORLA ONCOLOGY compare to other FdaApprovalPulse records?
It is 20 days old, still within a typical 45-day follow-up window.
SHORLA ONCOLOGY vs. top 3 peers
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FdaApprovalPulse: Drug labeling or REMS supplement
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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.