FDA rejects Savara’s rare lung disease drug over limited manufacturing data

The FDA has rejected Savara’s application for its rare lung disease candidate over insufficient chemistry, manufacturing and controls data, the clinical-stage biotech said Tuesday. Savara said it received a refuse-to-file ...

May 27, 2025 - 18:14
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FDA rejects Savara’s rare lung disease drug over limited manufacturing data
The FDA has rejected Savara’s application for its rare lung disease candidate over insufficient chemistry, manufacturing and controls data, the clinical-stage biotech said Tuesday. Savara said it received a refuse-to-file ...