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.

Biosimilars and sNDA/sBLA filings and resubmissions are 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.

Financial data are delayed 15-35 minutes.

Subscribe HERE to ensure you receive your weekly FREE copy of the BioPharmCatalyst Biotech Watchlist and/or our daily option of Biotech Price Movers and Pipeline Database updates