FDAsafety guidance72% confidence
Rare Disease Drug Approvals
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Roche.
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
- Neurology · Parkinson's Disease
- Sub-indication
- General
Related signal: Hoffmann-La Roche's Prasinezumab Trial Targets Early-Stage Parkinson's Disease