Monday, September 25, 2017
=Aradigm (ARDM): FDA acceptance of NDA for Linhaliq with priority review status
FDA has accepted for filing with Priority Review its NDA for Linhaliq the treatment of non-cystic fibrosis bronchiectasis patients with chronic infections with Pseudomonas aeruginosa
Co states, "The granting of Priority Review for the Linhaliq NDA accelerates the timing of the FDA review of the application compared to a standard review. The PDUFA goal date for completion of the FDA review of the Linhaliq NDA is January 26, 2018."
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