Every public company with an active or historical NDA/BLA in openFDA's Drugs@FDA database, tracked through clinical trials (ClinicalTrials.gov), filed applications (openFDA), and PDUFA target action dates — which have no official FDA feed and are extracted from the sponsor's own SEC filings, so each dated entry carries a confidence and a “Confirmed”/“Unconfirmed” badge. Treat an unconfirmed date as a lead, not a fact, and check the linked source filing.