PDUFA Calendar


PDUFA dates for biotech stocks. Advisory Committee Meeting calendar dates also included. 

Note that most large cap companies do NOT announce PDUFA dates. Caution is advised as many are ESTIMATED dates.

sNDA/sBLA filings and resubmissions are generally only noted if a PDUFA date has been released by the company. No official PDUFA date = No entry. (e.g. Saxagliptin and dapagliflozin resubmission). Standard reviews use a 10 month estimate following filing acceptance for a NEW MOLECULAR ENTITY if no PDUFA date has been announced.

PDUFA dates and Advisory Committee Meeting dates may also be viewed on the BioPharmCatalyst FDA Calendar.

Recent FDA decisions and Advisory Committee vote outcomes are found on the BioPharmCatalyst Historical Catalyst Calendar.

Click on the STOCK TICKER for more information about the respective companies.

Financial data are delayed 15-35 minutes.

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