PDUFA Dates May 2027
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.
- PDUFA decision BBIO BridgeBio Pharma, Inc. PDUFA target action date: BridgeBio Pharma, Inc. 2027-05-08
- PDUFA decision ZBIO Zenas BioPharma, Inc. PDUFA target action date: Zenas BioPharma, Inc. 2027-05-27
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