Thursday, February 27, 2014

Actelion diarrhea treatment gets fast-track from U.S. FDA

ZURICH (Reuters) - Actelion Ltd, Europe's biggest biotech company, said on Thursday that the U.S. health regulator has granted fast-track status to its antibiotic treatment for diarrhea. A fast track designation by the U.S. Food and Drug Administration (FDA) speeds up regulatory review of drugs that aim to treat serious diseases and fill unmet medical needs. Actelion said the FDA was also designating Cadazolid as a treatment for infectious diseases, which means the drug would get a nine-month priority review if it completes current late-stage trials successfully. ...



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