Research / FdaApprovalPulse
New FDA PMA Device, NDA, Generic (ANDA), BLA & Drug Supplement Approvals by Sponsor: 2026 statistics from 1,959 public records
California leads with 110 of 1,959 records (5.6%), ahead of Minnesota with 61 (3.1%) (as of 2026-11-03; source: 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)
Key findings
- Zalwin's FdaApprovalPulse dataset holds 1,959 FdaApprovalPulse records dated 2026-05-01 to 2026-10-28 (as of 2026-11-03; source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)). #
- California leads with 110 of 1,959 records (5.6%), ahead of Minnesota with 61 (3.1%) (as of 2026-11-03; source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)). #
- The most common approval type is Drug labeling or REMS supplement: 1,174 of 1,959 records (59.9%) (as of 2026-11-03; source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)). #
- 227 of 1,959 records (11.6%) are dated within the 30 days before 2026-11-03 (source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)). #
- In California, the leading approval type is PMA supplement (device change) with 105 of 110 records (95.5%) (as of 2026-11-03; source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)). #
FdaApprovalPulse records by state
| Group | Records | Share |
|---|---|---|
| California | 110 | 5.6% |
| Minnesota | 61 | 3.1% |
| Massachusetts | 37 | 1.9% |
| Oregon | 20 | 1.0% |
| Arizona | 18 | 0.9% |
| Texas | 18 | 0.9% |
| Illinois | 9 | 0.5% |
| Maryland | 9 | 0.5% |
| Tennessee | 8 | 0.4% |
| Pennsylvania | 7 | 0.4% |
| Florida | 6 | 0.3% |
| Washington | 6 | 0.3% |
| Missouri | 5 | 0.3% |
| Wisconsin | 5 | 0.3% |
| Colorado | 4 | 0.2% |
FdaApprovalPulse records by approval type
| Group | Records | Share |
|---|---|---|
| Drug labeling or REMS supplement | 1,174 | 59.9% |
| PMA supplement (device change) | 367 | 18.7% |
| Generic drug approval (ANDA) | 194 | 9.9% |
| Drug efficacy supplement (new indication or use) | 76 | 3.9% |
| Drug manufacturing (CMC) supplement | 55 | 2.8% |
| New drug application (NDA) | 40 | 2.0% |
| PMA original approval (new class III device) | 24 | 1.2% |
| Biologic license (BLA) | 17 | 0.9% |
| Other drug supplement | 12 | 0.6% |
Methodology and data provenance
- Sample: 1,959 public records dated 2026-05-01 to 2026-10-28; illustrative samples excluded.
- Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration). Refreshed automatically about every 24 hours; figures above are as of 2026-11-03.
- Shares are of all records in the dataset; totals and medians use only records with a stated amount.
- Organization-level data only. Informational; verify individual records at the official source.
Cite this study
Zalwin Research, "FdaApprovalPulse statistics" (data as of 2026-11-03), https://zalwin.com/research/fdaapprovalpulse
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