get_fda_approvals
shallowcom.keyvex/keyvex · Verify this server
Returns FDA approval / clearance events: drug approval actions from Drugs@FDA, medical-device 510(k) clearances, and device PMA (premarket approval) decisions. Full history (drugs to 1939, 510(k) to 1976, PMA to the 1960s). This is the BULLISH twin of get_product_recalls — the catalyst dataset for biotech and medtech tickers. Use this when the user asks about: new drug approvals for a company or ingredient, priority-review approvals, tentative generic (ANDA) approvals, device clearances by company or product code, PMA supplements, or to pair an approval date with insider trades / 8-K filings / fundamentals. Sources (filter via the `source` enum): drugsfda — Drugs@FDA submission actions. One record per submission decision (ORIG = original approval, SUPPL = supplemental). decision_code: AP (approved) | TA (tentative approval — generic approved but blocked by patent/exclusivity). review_priority: PRIORITY | STANDARD — PRIORITY reviews are the higher-signal events. application_number prefix tells the product class: NDA (new drug), ANDA (generic), BLA (biologic). 510k — Device premarket notifications. decision_code SESE ('substantially equivalent' — cleared) dominates ~98%. approval_type: Traditional | Special | Abbreviated. pma — Device premarket approvals (Class III, highest-risk devices — implants, life-sustaining). Originals AND supplements (supplement_number, supplement_reason). decision_code: APPR (approved) | OK30 (30-day supplement accepted) dominate. openFDA ships no description text for PMA codes; decision_description mirrors the code. review_priority='EXPEDITED' marks devices under expedited review; 'PRIORITY' marks priority-review drugs. Empty = standard / not flagged. Company matching: `applicant` is a substring filter on the sponsor / applicant name AS FILED (e.g., 'Pfizer', 'Boston Scientific'). FDA records carry no ticker or CIK — subsidiaries file under their own names, so try the operating-company name, not the holding company. source_url points at the accessdata.fda.gov detail page (approval letters, labels, review documents). Pure-publisher posture: no derived 'approval odds' or price-impact signals.
1 trials · measured 2 days ago
get_fda_approvals scores 100.0/100 on Vouch's measured behaviour index, from 1 real invocation trials against com.keyvex/keyvex, measured 6 Oct 2026 under methodology v0.2.0. Every measured component scored 100.
Component breakdown
| Component | Weight | Value |
|---|---|---|
| Reliability | 35% | not applicable |
| Schema integrity | 25% | 100.0 |
| Failure behaviour | 15% | not applicable |
| Latency | 15% | not applicable |
| Concurrency | 10% | not applicable |
Tool details
- Transport
- remote
- Credential class
- self-provisionable
- Input schema
- not declared
- Output schema
- not declared
- Side-effect classification
- unclassified
Score history
| Day | Score | Tier | Methodology |
|---|---|---|---|
| 2026-10-06 | 100.0 | shallow | v0.2.0 |
Probe evidence
| Probe | Outcomes |
|---|---|
| schema_integrity | pass: 1 |
Raw request/response logs are not archived yet — the outcome counts above are drawn directly from every recorded trial.
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