FDAsafety guidance83% confidence
Rare Disease Drug Approvals
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to IMVT-1402.
Regulatory Analysis
This page describes recent rare disease drug approvals that received CDER or FDA communication. This is not an exhaustive list of all rare disease drug approvals.
Supporting Context
- Therapeutic area
- Endocrinology · Graves' Disease
- Sub-indication
- General
Related signal: Immunovant's IMVT-1402 Enters Phase 2b for Graves' Disease Treatment