Monday, November 30, 2015

DMD Drugs: An Existential Threat To The FDA?

Last week saw the advisory committee meeting for drisapersen, the last of three new candidate treatments for Duchenne Muscular Dystrophy (DMD) to begin the process for approval in 2015. The outcome is clearly important for patients with DMD and their families. Equally, it is important to the companies who have developed these drugs, and their investors. What may be less obvious is that the outcome could be just as critical for the FDA itself.

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