PDUFA Dates September 2023
A PDUFA date is the FDA’s target deadline to complete its review of a drug application under the Prescription Drug User Fee Act. Approval, a Complete Response Letter, or a delay on this date is one of the largest single-day catalysts a biotech stock has. Dates below are extracted from company 8-K filings and official notices, with the source linked on every event.
No confirmed PDUFA decision events tracked for September 2023 yet. PDUFA dates surface when companies disclose them in filings — check back, or watch the 14-day window.
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