Close to a year ago Switzerland’s Basilea raised a red flag about its U.S. strategy for its antibiotic ceftobiprole, noting that the FDA’s new standard requiring two late-stage studies for a program like this could present a major hurdle. Today company execs confirmed that the regulatory path into the U.S. is closed for now.

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Source: FDA bars Basilea antibiotic from U.S. market, demands new PhIII data


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