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Search for companies, drugs, and catalysts
Search for companies, drugs, and catalysts
Search for companies, drugs, and catalysts
FDA target action dates for drug approval decisions. Track all upcoming PDUFA dates for biotech stocks.
There are no pending pdufa dates at this time.
FDA target action dates for drug approval decisions. Track all upcoming PDUFA dates for biotech stocks.
A PDUFA date is the deadline by which the FDA must make a decision on a drug application. These dates are set according to the Prescription Drug User Fee Act, which requires the FDA to complete reviews within specific timeframes. Standard reviews have a 10-month deadline, while priority reviews are completed in 6 months.
PDUFA dates are binary events that can cause significant stock price movements. An approval can send shares soaring, while a rejection, complete response letter (CRL), or delay can result in sharp declines. Investors track these dates closely to anticipate volatility.