Regulatory & compliance

FDA Approvals & Clearances

Returns FDA approval and clearance events — drug approval actions from Drugs@FDA (with PRIORITY/STANDARD review flags), medical-device 510(k) clearances, and PMA decisions. Full history: drugs to 1939, 510(k) to 1976, PMA to the 1960s. The bullish twin of Product Recalls — the catalyst dataset for biotech and medtech tickers.

EndpointGET /v1/fda-approvals

SourceopenFDA (Drugs@FDA + 510(k) + PMA)

Authx-api-key — a free key works

What it returns

One record per decision event (drug submission, 510(k) clearance, or PMA original/supplement). See the live example below for the full field set.

Filters

id	Direct lookup ('drugsfda-{applNo}-{subType}{n}', '510k-{kNumber}', 'pma-{pmaNumber}-{suppl\|ORIG}'). Fastest path.
source	Filter to one feed: drugsfda (drug approval actions), 510k (device clearances), pma (Class III device approvals).
category	Coarser filter: drug (= drugsfda) or device (= 510k + pma together).
application_number	Exact match on the FDA application number (e.g., 'NDA020123', 'ANDA213414', 'K260369', 'P250013').
applicant	Case-insensitive substring against the sponsor / applicant company name (e.g., 'pfizer', 'medtronic').
product_name	Case-insensitive substring against product/trade/device name AND generic name / active ingredients (e.g., 'semaglutide', 'stent').
decision_code	Exact decision code: AP / TA (drugs), SESE etc. (510k), APPR / OK30 etc
review_priority	PRIORITY (drugs), STANDARD (drugs), or EXPEDITED (devices). The high-signal filter for catalyst hunting.
product_code	Exact FDA device product code (e.g., 'OLO', 'MNQ'). Devices only.
since	Decision date lower bound (YYYY-MM-DD inclusive).
until	Decision date upper bound (YYYY-MM-DD inclusive).
sort_order	Default: desc (most recent decisions first).
limit	Maximum events to return. Default 50, max 500.

Example request

curl "https://api.keyvex.com/v1/fda-approvals?limit=1" \
  -H "x-api-key: YOUR_KEY"

Response

{
  "results": [
    {
      "supplement_number": "4",
      "approval_type": "SUPPL",
      "generic_name": "OLEZARSEN SODIUM",
      "review_priority": "PRIORITY",
      "source": "drugsfda",
      "product_code": "",
      "product_name": "TRYNGOLZA (AUTOINJECTOR)",
      "source_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218614",
      "applicant": "IONIS PHARMS INC",
      "dosage_form": "SOLUTION;SUBCUTANEOUS",
      "decision_code": "AP",
      "decision_date": "2026-06-24",
      "advisory_committee": "",
      "supplement_reason": "",
      "application_number": "NDA218614",
      "id": "drugsfda-NDA218614-SUPPL4",
      "category": "drug",
      "decision_description": "Approved",
      "_first_seen_at": "2026-07-05T22:37:28.731Z",
      "_last_history_at": "2026-07-05T22:37:28.731Z",
      "_content_hash": "4c5688cb47aa5765a6c25822587251d82c224c55db98f07b3d028fad91597bfd",
      "scraped_at": "2026-07-05T23:12:31.866Z"
    }
  ],
  "count": 1,
  "has_more": true
}

Example questions you can answer

Priority-review drug approvals this quarter.
A company's device clearances by product code.
Tentative generic (ANDA) approvals blocked by exclusivity.
Pair an approval date with insider trades or an 8-K.

Related datasets

Product RecallsFDA + CPSC — the bearish twin Insider TransactionsSEC Form 4 / 5 Material Events (8-K)SEC Form 8-K Corporate PatentsUSPTO

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