get_fda_approvals
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.
Input Schema
| Name | Required | Description | Default |
|---|---|---|---|
| id | No | Direct lookup ('drugsfda-{applNo}-{subType}{n}', '510k-{kNumber}', 'pma-{pmaNumber}-{suppl|ORIG}'). Fastest path. | |
| limit | No | Maximum events to return. Default 50, max 500. | |
| since | No | Decision date lower bound (YYYY-MM-DD inclusive). | |
| until | No | Decision date upper bound (YYYY-MM-DD inclusive). | |
| source | No | Filter to one feed: drugsfda (drug approval actions), 510k (device clearances), pma (Class III device approvals). | |
| category | No | Coarser filter: drug (= drugsfda) or device (= 510k + pma together). | |
| applicant | No | Case-insensitive substring against the sponsor / applicant company name (e.g., 'pfizer', 'medtronic'). | |
| sort_order | No | Default: desc (most recent decisions first). | |
| product_code | No | Exact FDA device product code (e.g., 'OLO', 'MNQ'). Devices only. | |
| product_name | No | Case-insensitive substring against product/trade/device name AND generic name / active ingredients (e.g., 'semaglutide', 'stent'). | |
| decision_code | No | Exact decision code: AP / TA (drugs), SESE etc. (510k), APPR / OK30 etc. (PMA). | |
| review_priority | No | PRIORITY (drugs), STANDARD (drugs), or EXPEDITED (devices). The high-signal filter for catalyst hunting. | |
| application_number | No | Exact match on the FDA application number (e.g., 'NDA020123', 'ANDA213414', 'K260369', 'P250013'). |