Drugs
Insmed sNDA Gets Priority Review for Arikayce Full Approval
FDA has accepted for priority review an Insmed supplemental NDA seeking traditional approval for Arikayce (amikacin liposome inhalation suspension) for treating Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen. The agency has set a user fee review action target date of 1/28/2027.