Where do the FDA articles come from?

Two feeds, both in the regulatory category: a Google News scope on fda.gov (press announcements, approvals, recalls, safety communications) and an approvals query across the financial press that catches the market reaction and tags the ticker. Both are polled every five minutes; the sec.gov, ftc.gov and fca.org.uk feeds are polled directly.

Are the articles tagged with the company's ticker?

Yes — the tagger matches cashtags, exchange prefixes like (NASDAQ: RARE), bare symbols and company names against the SEC universe, and drops disease acronyms that collide with symbols (a "wet AMD" drug is not Advanced Micro Devices). FDA's own announcements name the sponsor, so they tag too.

Is there a separate endpoint for FDA news?

Not a dedicated one; regulatory is a category, so it works everywhere categories work: GET /v1/news?category=regulatory, GET /v1/news/category/regulatory, and categories=regulatory on the stream. Add search=FDA to narrow it, or a ticker.

Does this cover the PDUFA calendar?

Not as structured dates. It covers what is published about the decision — the approval, the CRL, the delay — the moment it hits the wire or the press. Pair it with a PDUFA calendar for the schedule and this feed for the outcome.

FDA approval news feed: catch approvals, CRLs and recalls by ticker

FDA decisions are the sharpest single-name catalysts in the market. One category filter gives you approvals, complete response letters and recalls tagged to the ticker — over REST or as a push feed.

Updated 2026-09-20 · 5 min read · every example runs against the live API

A biotech can move 30% on a Friday-afternoon approval or lose half its value on a complete response letter, and the announcement usually lands on fda.gov, on the wire and in the press within the same hour. The H1 News API folds those into a regulatory category alongside SEC, FTC, CFTC and FCA actions, tagged with the ticker and scored for sentiment.

The query

FDA news, last 7 days

curl -H 'X-API-Key: YOUR_KEY' \
  'https://api.heliusone.com/v1/news?category=regulatory&search=FDA&date=last7days&limit=20'

A representative slice of what came back on a Friday evening:

results (abridged)

{"title": "Ultragenyx Pharmaceutical stock gains after FDA approval and fresh analyst targets",
 "source": "Google News: FDA Approvals", "tickers": ["RARE"],
 "sentiment": {"label": "positive", "score": 0.76}, "category": "regulatory",
 "published_at": "2026-09-19T18:43:08+00:00"}
{"title": "OTLK Stock Jumps Overnight After FDA Approval Of Wet AMD Drug — Analysts See Nearly 300% Upside",
 "source": "Google News: FDA Approvals", "tickers": ["OTLK"],
 "sentiment": {"label": "positive", "score": 0.70}, "category": "regulatory",
 "published_at": "2026-09-19T18:34:21+00:00"}
{"title": "Amneal Pharmaceuticals stock gains after FDA approval for lanreotide injection",
 "source": "Google News: FDA Approvals", "tickers": ["AMRX"],
 "sentiment": {"label": "positive", "score": 0.62}, "category": "regulatory",
 "published_at": "2026-09-19T18:17:34+00:00"}

Each row tells you the sponsor's ticker, the market's read (sentiment.score from −1 to +1) and the exact publication time in UTC. The url field, omitted above, links to the article or the FDA announcement.

Rejections, CRLs and clinical holds

The downside events are the ones a risk desk cares about, and they are phrased consistently enough to search:

negative decisions

# Rejections and delays, which move a biotech harder than approvals
curl -H 'X-API-Key: YOUR_KEY' \
  'https://api.heliusone.com/v1/news?category=regulatory&search=complete%20response%20letter%20OR%20FDA%20rejects%20OR%20clinical%20hold&date=last30days'

Combine with sentiment=negative to drop the "despite the CRL, analysts remain bullish" coverage.

One company

by ticker (Basic plan)

# Everything regulatory about one name, on Basic
curl -H 'X-API-Key: YOUR_KEY' \
  'https://api.heliusone.com/v1/news?ticker=RARE&category=regulatory&date=last30days'

Pro keys can pass up to 25 tickers per call — a whole biotech watchlist in one request — or use collection= baskets.

As a push feed

stream (Pro)

from h1news import AsyncH1News
import asyncio

async def main():
    async with AsyncH1News("sk_...") as news:            # Pro
        async for a in news.stream(categories=["regulatory"]):
            if "FDA" in a["title"]:
                print(a["sentiment"]["label"], a["tickers"], a["title"])

asyncio.run(main())

Subscribe to categories=["regulatory"] and the articles arrive as they are ingested — the fda.gov scope and the approvals query are polled every five minutes, the SEC's own feed every minute, and the wire releases that usually accompany an approval on the 20-second tier. Filter on tickers to limit it to your names.

In Python

SDK

from h1news import H1News
news = H1News("sk_...")

fda = news.news(category="regulatory", search="FDA approval OR FDA approves", date="today")
for a in fda["results"]:
    print(a["tickers"], a["sentiment"]["score"], a["title"])

What else lives in `regulatory`

SEC press releases — enforcement actions, rule changes, trading suspensions (the suspensions also appear as H10 halts in category=halts).
FTC — merger challenges, consent orders, consumer-protection actions; and the Antitrust & Regulation query feed across the press.
CFTC — derivatives enforcement and rulemaking.
UK FCA — fines, warnings, market announcements.

For the filings themselves — the 8-K a company files with the approval, the S-1 before an IPO, the SC 13D when an activist appears — use category=filings or GET /v1/news/filings?form=8-K.

Questions

Where do the FDA articles come from?: Two feeds, both in the regulatory category: a Google News scope on fda.gov (press announcements, approvals, recalls, safety communications) and an approvals query across the financial press that catches the market reaction and tags the ticker. Both are polled every five minutes; the sec.gov, ftc.gov and fca.org.uk feeds are polled directly.
Are the articles tagged with the company's ticker?: Yes — the tagger matches cashtags, exchange prefixes like (NASDAQ: RARE), bare symbols and company names against the SEC universe, and drops disease acronyms that collide with symbols (a "wet AMD" drug is not Advanced Micro Devices). FDA's own announcements name the sponsor, so they tag too.
Is there a separate endpoint for FDA news?: Not a dedicated one; regulatory is a category, so it works everywhere categories work: GET /v1/news?category=regulatory, GET /v1/news/category/regulatory, and categories=regulatory on the stream. Add search=FDA to narrow it, or a ticker.
Does this cover the PDUFA calendar?: Not as structured dates. It covers what is published about the decision — the approval, the CRL, the delay — the moment it hits the wire or the press. Pair it with a PDUFA calendar for the schedule and this feed for the outcome.

Publisher and product names on this page are trademarks of their respective owners and are used only to identify sources and compared services; no affiliation, sponsorship or endorsement is implied.

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