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 nontuberculous mycobacterial lung disease patients.
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
- Pulmonology · Nontuberculous Mycobacterial Lung Disease
- Sub-indication
- General
Related signal: Inhaled 3% hypertonic saline shows promise for antibiotic-naïve NTM lung disease