Merck MRK
said today it has started a rolling submission to the U.S. Food and Drug
Administration (FDA) of a Biologics License Application for MK-3475, the
company's investigational anti-PD-1 immunotherapy, for patients with
advanced melanoma who have been previously treated with ipilimumab. A
rolling submission allows completed portions of the application to be
submitted and reviewed by the FDA on an ongoing basis. The company
expects to complete the application in the first half of 2014.
See full press release
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