FDA Catalyst Calendar

Event Type All Events PDUFA Dates AdCom Meetings Approvals CRLs Phase 3 Readouts Phase 2 Readouts NDA/BLA Filings Breakthrough Fast Track Priority Review Class I Recalls Class II Recalls Warning Letters

Status Upcoming Completed

Time Range Next 2 Weeks Next 30 Days Next 90 Days Next 6 Months Next Year

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About This Calendar

Catalyst events are compiled from official public sources: FDA press releases (fda.gov), SEC EDGAR 8-K filings, company press releases via GlobeNewsWire and PR Newswire. PDUFA target action dates are sourced from company SEC filings and press releases — the FDA does not publish a public PDUFA calendar. Dates are targets and may change due to FDA extensions, Major Amendments, or NDA withdrawals.

Data updates every 15 minutes. Historical events reflect the date the information was published, not necessarily the date of the FDA action.