Amikacin liposome inhalation suspension, sponsored by Insmed, Inc., for the proposed indication of treatment of nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex in adults as part of a combination antibacterial drug regimen

Results from assessments of the transmucosal immediate-release fentanyl (TIRF) medicines’ risk evaluation and mitigation strategy (REMS)

Tafenoquine tablet, 100 milligram (mg), sponsored by 60 Degrees Pharmaceuticals, for the proposed indication of prevention of malaria in adults for up to 6 months of continuous dosing

Tafenoquine tablet, 150 milligram, sponsored by GlaxoSmithKline, for the proposed indication of the radical cure (prevention of relapse) of Plasmodium vivax malaria