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 Eli Lilly.
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
- Infectious Disease · Viral and Bacterial Pathogens
- Sub-indication
- General
Related signal: Lilly expands infectious disease portfolio with three strategic acquisitions