PDUFA Calendar

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

The PDUFA date refers to the date the Food and Drug Administration (FDA) are expected to deliver their decision whether or not a approve a companies New Drug Application (NDA) or Biologics License Application (BLA).

If a NDA is deemed to be complete the FDA has 10 months to review the application. Under a priority review the timeline is shortened to 6 months.

On the PDUFA date the FDA will either:

- issue approval for marketing.

- issue a Complete Response Letter (CRL) - i.e. rejection letter.

Note that most large cap companies do NOT announce PDUFA 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.

NASDAQ and NYSE stocks only are shown. OTC stocks are not covered on BioPharmCatalyst.

Click on the date for the source of the catalyst.

Financial data are delayed 15-25 minutes.