Distalmotion seeks FDA clearance for DEXTER use
The FDA has authorised the company to begin a US myomectomy trial through an investigational device exemption.
02 April 2026
02 April 2026
The FDA has authorised the company to begin a US myomectomy trial through an investigational device exemption.
Actinogen anticipates final topline efficacy and safety results for the full 36-week treatment period in November 2026.
The collaboration will focus on advanced therapies, including weight loss.
Lumitrace is currently approved in China and the US, with submission to EU regulatory authorities pending.
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