FDA calls for additional manufacturing data in refusal letter for Savara's respiratory asset

The FDA has slapped Savara with a refuse to file letter after the biotech in March applied for approval of its inhaled respiratory disease candidate molgramostim in autoimmune pulmonary alveolar proteinosis.

May 27, 2025 - 16:10
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FDA calls for additional manufacturing data in refusal letter for Savara's respiratory asset
The FDA has slapped Savara with a refuse to file letter after the biotech in March applied for approval of its inhaled respiratory disease candidate molgramostim in autoimmune pulmonary alveolar proteinosis.