Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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Patient testimony to the contrary, advisory committee members were not persuaded that PTC Therapeutics' ataluren, which failed its primary endpoint in two trials, is effective in treating nonsense mutation Duchenne muscular dystrophy.
The Bone, Reproductive and Urologic Drugs Advisory Committee will consider endpoints, clinical trial designs and other issues related to development in the disease.
Voretigene neparvovec moves closer to being the first to market a gene therapy in the US with FDA advisory committee review on Oct. 12.