US FDA Needs More Time To Review Clinuvel’s Scenesse For Phototoxicity
Executive SummaryThe user fee goal date for the Food and Drug Administration’s review of Scenesse has been put back from July to October to allow more time to examine the therapy’s benefit-risk profile.
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The latest drug development news and highlights from our US FDA Performance Tracker.
First-in-class drug for rare disease EPP obtains FDA approval, company plans treatment center-based rollout. Scenesse, on the market in Europe since 2016, has faced reimbursement hurdles.