La Jolla’s Giapreza: Emergency Use Requests Sped US FDA Approval For Septic Shock
After publication of ATHOS-3 study results, agency received several requests from medical community for emergency use in hospitalized patients with shock and hypotension unresponsive to available therapy, spurring FDA to take an approval action two months ahead of user fee goal date.
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Having recently bought antibacterial developer Entasis, Innoviva adds approved antibiotic Xerava and hypotension drug Giapreza to its portfolio along with La Jolla’s established commercial organization.
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