Miles To Go Before Savient Krystexxa Approval; REMS Talks Are Next Step

Now that gout drug candidate Krystexxa has passed muster with FDA's Arthritis Drugs Advisory Committee, its next major hurdle is agency approval. But with only six weeks to go until its Aug. 1 user fee date and what's expected to be a fairly complex Risk Evaluation and Mitigation Strategy, odds are FDA will be unable to meet that timeline