PDUFA dates for biotech companies. Advisory Committee Meeting calendar dates also included.
LARGE cap companies are now listed. There is an ERROR with the financial data with price showing $0.00. A new API is being sourced to rectify the issue.
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.
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