FDA Catalyst Alerts

Monitor FDA catalysts for biotech trading signals. Track PDUFA dates, Phase 3 completions, safety signals, recalls, and FDA decisions. Get alerts via webhook when catalysts are approaching.

What This Actor Does

• PDUFA Date Tracking: Scrapes upcoming FDA decision dates from RTTNews FDA Calendar
• Phase 3 Trial Monitoring: Alerts when Phase 3 trials complete or approach completion dates
• Safety Signal Detection: Detects spikes in adverse event reports (FAERS)
• Recall Monitoring: Tracks FDA drug and device recalls
• FDA Decision Tracking: Monitors recent approvals and CRLs from FDA press releases
• Ticker Mapping: Maps drug and sponsor names to stock tickers using a built-in curated list (~50 pharma/biotech name mappings)

Use Cases

• Biotech Traders: Get ahead of market-moving FDA events
• Portfolio Managers: Monitor drug pipelines in your holdings
• Risk Management: Detect safety signals before they impact stock price
• Event-Driven Strategies: Track binary catalyst events

Example Input

{
  "watchlist": ["Keytruda", "Humira", "Opdivo", "Dupixent"],
  "watchlistTickers": ["MRK", "ABBV", "BMY", "REGN"],
  "alertDaysBefore": [30, 14, 7, 1],
  "catalystTypes": ["PDUFA_DATE", "PHASE3_COMPLETION", "PHASE3_RESULTS", "SAFETY_SIGNAL", "RECALL", "APPROVAL", "CRL"],
  "safetySignalThreshold": 100,
  "webhookUrl": "https://hooks.slack.com/services/xxx",
  "webhookFormat": "slack",
  "openfdaApiKey": "your-openfda-api-key"
}

Catalyst Types

Type	Description	Source
PDUFA_DATE	Upcoming FDA decision date	RTTNews FDA Calendar
PHASE3_COMPLETION	Phase 3 trial completing	ClinicalTrials.gov
PHASE3_RESULTS	Phase 3 results posted	ClinicalTrials.gov
SAFETY_SIGNAL	Adverse event spike detected	openFDA FAERS
RECALL	FDA recall announced	openFDA Enforcement
APPROVAL	FDA approval announced	FDA Press Releases
CRL	Complete Response Letter issued	FDA Press Releases

Alert Severity

Severity	Meaning
CRITICAL	Event happened or Class I recall
HIGH	Event within 7 days
MEDIUM	Event within 14 days
LOW	Event beyond 14 days

Webhook Integration

Supports Slack, Discord, or generic webhooks. Only CRITICAL and HIGH severity alerts are delivered to the webhook; every catalyst and alert is still saved to the dataset regardless of severity.

Slack Format

{
  "webhookUrl": "https://hooks.slack.com/services/...",
  "webhookFormat": "slack"
}

Discord Format

{
  "webhookUrl": "https://discord.com/api/webhooks/...",
  "webhookFormat": "discord"
}

Scheduling

For continuous monitoring, schedule this actor to run daily:

• Every morning before market open (8 AM ET)
• Use Apify's built-in scheduler

Input Parameters

Parameter	Type	Default	Description
watchlist	array	[]	Drug names to monitor
watchlistTickers	array	[]	Stock tickers (optional, auto-resolved if not provided)
alertDaysBefore	array	[30, 14, 7, 1]	Days before event to trigger alerts
catalystTypes	array	["PDUFA_DATE", "PHASE3_COMPLETION", "SAFETY_SIGNAL", "RECALL"]	Which catalyst types to check (also supports PHASE3_RESULTS, APPROVAL, CRL)
safetySignalThreshold	number	100	Minimum adverse events in the last 90 days to trigger a safety signal
includeAdverseEventSummary	boolean	true	Must be enabled for SAFETY_SIGNAL checks to run
webhookUrl	string	-	Webhook URL for alerts (only CRITICAL/HIGH alerts are sent)
webhookFormat	string	"generic"	Format: "slack", "discord", or "generic"
openfdaApiKey	string	-	Optional free openFDA API key for higher daily rate limits

Data Sources

• RTTNews FDA Calendar: PDUFA dates and FDA decision calendar
• ClinicalTrials.gov: Phase 3 trial data
• openFDA FAERS: Adverse event reports
• openFDA Enforcement: Drug/device recalls
• FDA Press Releases: Approval announcements

Ticker Mapping

The actor includes a curated list of major pharma/biotech companies (~50 sponsor and drug name mappings). If your watchlist item isn't recognized, provide the ticker manually in watchlistTickers.

Key-Value Store Schema

The actor stores the following data in the key-value store:

RUN_STATS

{
  "watchlistCount": 4,
  "catalystsFound": 12,
  "alertsTriggered": 5,
  "pdfuaDates": 3,
  "phase3Completions": 4,
  "safetySignals": 2,
  "recalls": 3
}

PREVIOUS_STATE

Used for tracking state between scheduled runs:

{
  "runDate": "2024-01-15T08:00:00.000Z",
  "catalystCount": 12,
  "alertCount": 5,
  "watchlist": ["Keytruda", "Humira", "Opdivo", "Dupixent"]
}

Limitations

• Not financial advice. Output is informational only and must not be treated as investment, trading, or medical advice. Past performance of catalyst-based strategies does not guarantee future results.
• Depends on external sources. Data comes from ClinicalTrials.gov, openFDA (FAERS and Enforcement), the RTTNews FDA calendar, and FDA press releases. If any of these changes its layout, rate-limits requests, or goes down, the corresponding catalyst type may return no results for that run.
• Watchlist-driven matching. Catalysts are only surfaced for the drug/company names you provide. Matching is name-based (case-insensitive substring), so misspellings or uncommon brand/generic names may be missed.
• Ticker coverage is limited. Auto-resolution uses a built-in curated list (~50 mappings). Unrecognized names return no ticker unless supplied via watchlistTickers.
• Safety signals use spontaneous reports. Adverse event counts come from FAERS spontaneous reporting and are not adjusted for exposure or verified for causation.
• PDUFA and decision scraping is best-effort. The RTTNews calendar and FDA press-release pages are HTML-scraped and may return partial or empty results if their markup changes.
• AdCom meetings are not included. The FDA advisory-committee calendar is JavaScript-rendered and is not scraped by this actor.
• Placeholder inputs. includeTrialData, emailAlerts, and previousRunDatasetId (change detection) appear in the input schema but are not yet wired into the run logic and currently have no effect.
• Possible empty dataset. When nothing matches (or all sources are unavailable), the run completes successfully and writes a single status record rather than failing.

Pricing

Priced via the Apify platform using compute units. Actual cost depends on your watchlist size, the number of catalyst types selected, and the built-in rate-limit delays between API calls — larger watchlists run longer and cost more.

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Built by JCD | Data from ClinicalTrials.gov, openFDA, FDA.gov & RTTNews