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Home » FDA Advisory Committee Signs Off on Risk-Benefit Profile of SIGA’s Smallpox NDA
FDA Advisory Committee Signs Off on Risk-Benefit Profile of SIGA’s Smallpox NDA
In a 17-0 vote, the FDA’s Antimicrobial Drugs Advisory Committee voted that the data show a favorable risk-benefit profile for TPOXX (tecovirimat) for its proposed indication for treating smallpox caused by variola virus in adults and pediatric patients.