Upcoming FDA PDUFA Decision Dates to Watch (June 2026)

The U.S. Food and Drug Administration issues decisions on drug applications by specific target dates, known as PDUFA decision dates. These regulatory milestones determine when the FDA will complete its review of new drug candidates submitted by pharmaceutical companies. The outcomes—approval, rejection, or request for additional information—can significantly impact biotech and pharmaceutical companies' clinical pipelines and business prospects.

Financial professionals and market participants closely monitor these decision dates because FDA approvals and denials can affect company valuations, stock price movements, and investor sentiment in the sector. This calendar lists upcoming PDUFA decisions ordered by expected date, linking each decision to the relevant company and drug candidate. Investors use this data to stay informed about key regulatory catalysts and industry developments as they unfold.

Upcoming FDA PDUFA Decision Dates

How this list is compiled

Events are sourced from public US-government and clinical-trial data (SEC filings, the Federal Register and ClinicalTrials.gov) and ordered by date. Dates can change; always confirm with primary sources. Figures are pulled automatically from MarketsHost data and refreshed regularly. This page is for general information only and is not investment, financial or trading advice.

For the underlying data, explore the BioPharma FDA catalyst tracker on MarketsHost.