NDA vs BLA — what's the difference?
New Drug Application for small molecules, Biologics License Application for biologics.
Small molecules (pills, synthetics) file NDAs under FD&C; biologics (antibodies, cell and gene therapies, vaccines) file BLAs under PHS. Both get PDUFA dates; both can be prioritized, fast-tracked, or met with CRLs.
BLA sponsors are also subject to facility inspections earlier in review — a common source of surprise delay.
See it live: the catalyst calendar · status-change feed