Takeda's GATTEX gets REMS-related supplement approved by FDA
FDA approved a REMS submission for GATTEX (teduglutide), Takeda's short bowel syndrome treatment, this week.
The only update this week involves a regulatory supplement to GATTEX's existing approval.
- GATTEX (teduglutide), a subcutaneous powder for injection sponsored by Takeda Pharmaceuticals USA, received approval for supplement number 28, classified as a REMS submission, with a submission status date of 2026-08-26.1
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