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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Aradigm's Linhaliq Suffers 'No' For Reducing Time To Exacerbations At US FDA Panel
Discordant results on Phase III primary endpoint in non-cystic fibrosis bronchiectasis patients troubled advisory committee members, although some suggested they would be more open to approval based upon secondary endpoint data on reduction in exacerbation frequency.
Lipocine's Tlando Falls Short At US FDA Advisory Cmte Over Blood Pressure Concerns
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Pacira's Exparel For Nerve Block Use Gets Day-Plus US FDA Panel Review
Pacira believes new clinical trial of post-surgical pain medication will satisfy FDA concerns raised in complete response letter for its supplemental NDA.