Non-tuberculous Mycobacterial Lung Disease

• EMA approval · 2025-10-14
  EMA Authorised: Arikayce liposomal (amikacin sulfate) — Insmed Netherlands B.V.

  The EMA authorised Arikayce liposomal amikacin sulfate for use in respiratory tract infections, with orphan medicine designation; the market…

• FDA approval · 2023-02-10
  FDA Approved: ARIKAYCE — Supplemental Application (Insmed Incorporated)

  FDA approved a supplemental application for ARIKAYCE (amikacin liposome inhalation suspension) from Insmed Incorporated. This action updates…

• FDA approval · 2020-10-19
  FDA Approved: ARIKAYCE — Supplemental Application (Insmed Incorporated)

  The FDA approved a supplemental application for ARIKAYCE (amikacin liposome inhalation suspension) from Insmed Incorporated. The action upda…