get_fda_approvals

shallow

com.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.

100.0/100

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

ComponentWeightValue
Reliability35%not applicable
Schema integrity25%100.0
Failure behaviour15%not applicable
Latency15%not applicable
Concurrency10%not applicable

Tool details

Transport
remote
Credential class
self-provisionable
Input schema
not declared
Output schema
not declared
Side-effect classification
unclassified

Score history

DayScoreTierMethodology
2026-10-06100.0shallowv0.2.0

Probe evidence

ProbeOutcomes
schema_integritypass: 1

Raw request/response logs are not archived yet — the outcome counts above are drawn directly from every recorded trial.

Embed this score

Available for every tool, scored or not — not a verification perk. Always links back to this page.

Vouch score: get_fda_approvals
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get_fda_approvals — Vouch