FdaApprovalPulse: New drug application (NDA)
40 fdaApprovalPulse: New drug application (NDA) are listed from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration), dated 2026-05-01 to 2026-10-20; the most frequent is FRESENIUS MEDCL CARE with 2. Data last updated 2026-11-03; each record links to its official source and a full report.
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Includes: Sponsor, Product, Approval, Decided, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe
40 records from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration), dated 2026-05-01 to 2026-10-20. Most frequent: FRESENIUS MEDCL CARE (2). Each record links to a full report and the official source.
Last updated 2026-11-03. Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
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- FRESENIUS MEDCL CARE (2)
- AZURITY (2)
- GILEAD SCIENCES INC (2)
- GLAXOSMITHKLINE LLC (1)
- ALCON LABS INC (1)
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What are the top fdaApprovalPulse: New drug application (NDA) right now?
| Record | Product | Approval | Decided |
|---|---|---|---|
| GLAXOSMITHKLINE LLC | HIBSAGO | New drug application (NDA) | 2026-10-20 |
| FRESENIUS MEDCL CARE | CIENBY | New drug application (NDA) | 2026-10-19 |
| FRESENIUS MEDCL CARE | CALREZDY | New drug application (NDA) | 2026-10-19 |
| ALCON LABS INC | BRYTLY | New drug application (NDA) | 2026-10-16 |
| COSETTE | EVOXAC | New drug application (NDA) | 2026-10-15 |
| BRACCO | ISOVUE READI | New drug application (NDA) | 2026-10-09 |
| TEVA | WELTRUZA | New drug application (NDA) | 2026-10-08 |
| EVER | TRABECTEDIN | New drug application (NDA) | 2026-10-01 |
| ABBVIE | JUVMO | New drug application (NDA) | 2026-09-25 |
| ADVENTAPHARMA | ZUEINO | New drug application (NDA) | 2026-09-25 |
| AZURITY | LAMLIQUE | New drug application (NDA) | 2026-09-25 |
| MIRUM | ATEBRIOZ | New drug application (NDA) | 2026-09-25 |
| ELEVAR | LYRFIGTU | New drug application (NDA) | 2026-09-23 |
| AGL WELDING SUPPLY CO INC DBA AGL GAS TECHNOLOGIES | CARBON DIOXIDE, USP | New drug application (NDA) | 2026-09-22 |
| CURIUM | BEXLUTRY | New drug application (NDA) | 2026-09-14 |
| TELIX | 🔒 Unlock all 40 records → | ||
| ASTRAZENECA | 🔒 Unlock all 40 records → | ||
| IONIS PHARMS INC | 🔒 Unlock all 40 records → | ||
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Which related categories and locations should I check?
Browse by approval type
Drug labeling or REMS supplement (1174) PMA supplement (device change) (367) Generic drug approval (ANDA) (194) Drug efficacy supplement (new indication or use) (76) Drug manufacturing (CMC) supplement (55) PMA original approval (new class III device) (24) Biologic license (BLA) (17) Other drug supplement (12)
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Frequently asked questions
How many fdaApprovalPulse: New drug application (NDA) are listed?
40 records from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration), last refreshed automatically. The most recent is dated 2026-10-20.
Can I get alerts for New drug application (NDA)?
Yes. FdaApprovalPulse can email you new records matching this filter; plans are listed on the FdaApprovalPulse page.
Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration). Informational only. RSS feed of new records