-- Savara (SVRA) said late Wednesday the US Food and Drug Administration has extended the review period for molgramostim biologics license application in autoimmune pulmonary alveolar proteinosis, a rare lung disease, by three months.
The new prescription drug user fee act target action date for the inhalation solution is Nov. 22, the company said.
The FDA did not cite any efficacy, safety, or manufacturing concerns, the company said, adding that the FDA determined that the responses to recent information requests represented a significant amendment to the application.