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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Postmarketing studies are needed to assess tafenoquine’s efficacy in children, older adults and heavier individuals, and to answer questions about psychiatric safety and other adverse events, advisory committee says.
Unclear data on monoclonal antibody's efficacy caused many members of Pulmonary-Allergy Drugs Advisory Committee to vote against recommending approval.
In its first quarter 2021 sales earnings report, Roche highlighted the strength of its diagnostics business as biosimilars cannibalize its pharmaceutical revenues. CEO Thomas Schinecker said the growth should continue.