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Benlysta Approved: FDA's Silence is Deafening

This article was originally published in RPM Report

Executive Summary

FDA’s approval of a new lupus therapy had all the elements of a big story to put the agency in a favorable light. But FDA took a decidedly low key approach to the decision, saying it didn’t want to “overhype” the product. That may be a missed opportunity for FDA’s image with key legislators—but it underscores the sense of ambivalence FDA had towards the product all along.

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