NUVALENT: New drug application for JIDEYTRO
NUVALENT: New drug application for JIDEYTRO. Dated 105 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 | NUVALENT |
| Product | JIDEYTRO |
| Generic / ingredient | ZIDESAMTINIB |
| Approval | New drug application (NDA) |
| Application | NDA220185 |
| Decided | 2026-07-22 |
| Panel / class | TABLET, ORAL |
| Peer records CSV (500 records) | 🔒 Click to unlock → |
| 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: 2026-07-22
- Data refreshed: 2026-11-04
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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 NUVALENT?
The FDA approved JIDEYTRO (NDA220185) for NUVALENT on 2026-07-22: new drug application (NDA).
How does NUVALENT compare to other FdaApprovalPulse records?
It is 105 days old; check the official source for later updates before acting.
NUVALENT vs. top 3 peers
| Organization | Record date |
|---|---|
| NUVALENT | 2026-07-22 |
| AVYXA HOLDINGS, LLC. | 2026-10-29 |
| GLAXOSMITHKLINE LLC | 2026-10-20 |
| FRESENIUS MEDCL CARE | 2026-10-19 |
Related records
FdaApprovalPulse: New drug application (NDA)
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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.