Novartis heart-failure drug wins ‘breakthrough’ status at FDA (Bloomberg Businessweek, 21 June 2013)

21 Jun 2013


The US Food and Drug Administration has granted "breakthrough" designation to Novartis' experimental synthetic relaxin drug (Serelaxin) in acute heart failure. Breakthrough status is designed to expediate the development of drugs for serious or life-threatening conditions, including fast-tracking through the approval process and intensive FDA guidance on an efficient drug development program.

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