The FDA approves GlaxoSmithKline's (GSK) raxibacumab injection to treat inhalational anthrax, a...
Friday, December 14, 2012, 4:13 PM ETThe FDA approves GlaxoSmithKline's (GSK) raxibacumab injection to treat inhalational anthrax, a form of the infectious disease caused by breathing in the spores. Raxibacumab is the first monoclonal antibody approved under the FDA’s Animal Efficacy Rule, which allows findings from animal studies to support FDA approval when it is not feasible or ethical to conduct trials in humans. In this case, because inhalational anthrax is a rare and lethal disease, it is not possible to conduct adequate trials in humans.
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