Horizon Teprotumumab's US Advisory Cmte. Likely To Focus On Labeling, Not Approval, Questions
FDA seems poised to approve the drug for the orphan eye disease called TED, but remains concerned about labeling for some adverse events.
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Horizon CEO says safety trial will be conducted in a larger patient population following discussions during the US FDA advisory committee meeting.
Efficacy data were striking to committee members, but they want to ensure postmarketing plans gather adequate data to address safety questions.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.