Insmed follows a new pathway at the FDA for antibacterials, winning quick OK for Arikayce
The FDA granted accelerated approval for Insmed’s drug Arikayce for the treatment of a lung disease caused by the bacteria group Mycobacterium avium complex, or MAC, in certain patients who have not responded to conventional treatment. And regulators used the moment to flag a new pathway opened at the FDA that is intended to speed up the arrival of a new generation of badly needed antibacterials.
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