Biotech catalyst glossary
The FDA and clinical-trial vocabulary behind every date on our calendar and every row in the change feed.
- What is a PDUFA date?
- What is an AdCom (FDA advisory committee meeting)?
- What is a Complete Response Letter (CRL)?
- What is Breakthrough Therapy Designation (BTD)?
- What is Orphan Drug Designation (ODD)?
- What is Fast Track Designation?
- What is Priority Review?
- What is a Phase 3 readout?
- What is a primary completion date (on ClinicalTrials.gov)?
- What do ClinicalTrials.gov status changes mean?
- NDA vs BLA — what's the difference?
- What is a clinical trial endpoint?
- What is Accelerated Approval?
- What does 'FDA accepts our application' mean?
- What is a rolling submission?
- Sponsored vs investigator-initiated trials
- What is an enrollment halt?
- Why 8-K filings matter in biotech
- CRL vs RTF — two kinds of FDA rejection
- Estimated vs disclosed catalyst dates