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Approval of Raxibacumab for the Treatment of Inhalation Anthrax Under the US Food and Drug Administration “Animal Rule”

On December 14, 2012, the FDA approved Raxibacumab, the first monoclonal antibody product developed under Project BioShield to achieve this milestone, and the first biologic product to be approved through the FDA animal efficacy rule (or “Animal Rule”). Raxibacumab is approved for the treatment of a...

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Dettagli Bibliografici
Pubblicato in:Front Microbiol
Autori principali: Tsai, Chia-Wei, Morris, Stephen
Natura: Artigo
Lingua:Inglês
Pubblicazione: Frontiers Media S.A. 2015
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Accesso online:https://ncbi.nlm.nih.gov/pmc/articles/PMC4664625/
https://ncbi.nlm.nih.gov/pubmed/26648915
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.3389/fmicb.2015.01320
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