FDA & Regulatory
Biologics License Application
A Biologics License Application (BLA) is the marketing-approval request for a biologic — such as an antibody, vaccine, or cell or gene therapy. It is the biologics counterpart of the small-molecule NDA and likewise triggers a PDUFA date.
- Category
- FDA & Regulatory
- Abbreviation
- BLA
Prepared research question
How does Biologics License Application affect the view of a biotech company in practice?
Traceable citations · Unknowns marked
A Biologics License Application (BLA) is the marketing-approval request for a biologic — such as an antibody, vaccine, or cell or gene therapy. It is the biologics counterpart of the small-molecule NDA and likewise triggers a PDUFA date.
Related terms
From term to thesis rule
Investigate how Biologics License Application changes a biotech thesis
Define when Biologics License Application should count, block, or trigger a deeper check; BioSniper will compile that logic against available evidence.