FDA to review Blue Earth's Axumin for brain cancer

The U.S. Food and Drug Administration (FDA) has accepted molecular imaging firm Blue Earth Diagnostics' supplemental new drug application for the use of its Axumin (fluciclovine F-18) PET radiopharmaceutical in brain cancer detection.

This filing acceptance follows a recent phase III trial (BED006) that reported superior results in glioma diagnosis when using fluciclovine F-18 PET and MRI, compared with MRI alone. The radiopharmaceutical previously received FDA approval for the detection of prostate cancer.

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