FdaApprovalPulse: new FDA device and drug approvals as they happen
FdaApprovalPulse tracks 1,969 records from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration), last refreshed 2026-11-04, for contract manufacturers and API suppliers, packaging, labeling and serialization vendors, pharma and medtech commercialization agencies, distributors and GPO contracting teams, and competitive-intelligence analysts. Search, filter and preview free; CSV unlocks, alerts and API access start at $4.99. Every record links to its official source.
PMA approvals and supplements for class III devices, new drug, generic (ANDA) and biologic approvals, and approved drug supplements (labeling and REMS, manufacturing/CMC, efficacy) from Drugs@FDA, with sponsor, product, type and decision date. Filter by approval type and sponsor state.
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Long-tail intelligence feed for contract manufacturers and API suppliers, packaging, labeling and serialization vendors, pharma and medtech commercialization agencies, distributors and GPO contracting teams, and competitive-intelligence analysts
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
Score is a heuristic estimate, not advice.
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✓ Live public data, refreshed 2026-11-04 · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
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Top FdaApprovalPulse records
Latest top-scored records
| Record | Product | Approval | Decided |
|---|---|---|---|
| AVYXA HOLDINGS, LLC. | CISPLATIN | New drug application (NDA) | 2026-10-29 |
| AMGEN INC | PAVBLU | Biologic license (BLA) | 2026-10-22 |
| SANDOZ INC | ENZEEVU | Biologic license (BLA) | 2026-10-22 |
| GLAXOSMITHKLINE LLC | HIBSAGO | New drug application (NDA) | 2026-10-20 |
| FRESENIUS MEDCL CARE | CIENBY | New drug application (NDA) | 2026-10-19 |
Browse by approval type
Drug labeling or REMS supplement (1180) PMA supplement (device change) (367) Generic drug approval (ANDA) (196) Drug efficacy supplement (new indication or use) (77) Drug manufacturing (CMC) supplement (55) New drug application (NDA) (41) PMA original approval (new class III device) (24) Biologic license (BLA) (17) Other drug supplement (12)
Browse by sponsor state (devices)
California (110) Minnesota (61) Massachusetts (37) Oregon (20) Arizona (18) Texas (18) Illinois (9) Maryland (9) Tennessee (8) Pennsylvania (7) Florida (6) Washington (6) Missouri (5) Wisconsin (5) Colorado (4) Connecticut (4) Georgia (4) Indiana (4) New Jersey (4) New York (4) North Carolina (3) Ohio (3)
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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.