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Wire · operational-macro

FDA Grants Breakthrough Therapy Designation to 64Cu-SAR-bisPSMA for PSMA PET in ...

12 November 2026 · By · Wire by Fusion42

Published

12 November 2026

Topic

operational-macro

◆ Sectors

Medtech

◆ Geography

United States

◆ Source

Read at onclive.com →

◆ Verified

Fusion42 · 12 November 2026 · Fusion42 review

The FDA has granted Breakthrough Therapy Designation to 64Cu-SAR-bisPSMA for use in PSMA PET imaging of biochemically recurrent prostate cancer, accelerating its development and review.

This Wire brief sits within Fusion42's coverage of Medtech.

◆ ◆ The Wire takeaway

Medtech founders developing imaging agents for prostate cancer can now move faster on FDA approval with this designation. Your window to differentiate via regulatory speed just opened.

◆ Coverage

1 source · 12 Nov 2026

◆ Related on Wire

◆ Topics

Medtechfdabreakthrough-therapyprostate-cancerpet-imagingmedtech