RedHill Biopharma Ltd.
RHB-204
Crohn's disease
Date
TBD
Approval decision · Date TBD estimated
What's at stake
A final FDA approval decision on RHB-204 for Crohn's disease is expected Date TBD.
Primary source
· SEC 6-K
verified 12h ago
“Expected transferal of RHB-104’s FDA pediatric orphan drug designation to RHB-204, potential for breakthrough therapy designation, fast track designation, additional regulatory exclusivity and priority review voucher.”