Photocure ASA: FDA grants priority review for Cysview® supplemental New Drug Application (sNDA)
Oslo, Norway, October 18, Photocure ASA (OSE: PHO) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Cysview[®] on a priority review basis. With the FDA granting a priority review, a decision is expected in the first half of 2018. The company is looking to expand the label of Cysview to include its use in the outpatient setting to detect the recurrence of bladder cancer using a flexible cystoscope, the detection of carcinoma in situ (CIS) and the repeat administration of Cysview. The filing is a combination drug-