J&J/Basilea's ceftobiprole US approval delayed as FDA asks for trial site audits
The Food and Drug Administration says it cannot approve US health care major Johnson & Johnson's ceftobiprole for complicated skin and skin structure infections at this time. The FDA asked J&J to conduct additional audit work of clinical investigator sites and to address specific questions related to site monitoring. Shares in the drug's originator, Swiss firm Basilea, fell 31% on the news.
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