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You are here: Home / Drug-Device Combinations / Photocure wins FDA expanded sNDA for Blue Light Cytoscopy with Cysview system

Photocure wins FDA expanded sNDA for Blue Light Cytoscopy with Cysview system

February 20, 2018 By Fink Densford Leave a Comment

Photocure

Norwegian urology-focused developer Photocure ASA said last week it won a supplemental new drug application from the FDA extending the indication for its Blue Light Cytoscopy (BLC) with Cysview to include flexible cytoscopes designed for the surveillance of patients with bladder cancer.

The company touted the approval, saying it is the only combination of drugs and devices approved for detecting bladder cancer.

Read the whole story on our sister site, Drug Delivery Business

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Photocure ASA

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