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.

Other useful tools include:

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

Biotech Stocks - View the greatest Biotech Stock price advancers, decliners and those with unusual volume.

Drug Pipeline Database and Screener - Biotech Stock pipelines and financial data.

Biotech Historical Catalyst Calendar - List of completed catalysts going back to 2009.

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

Financial data are delayed 15-35 minutes.

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