The FDA has designated MyoKardia’s (NASDAQ:MYOK) mavacamten a Breakthrough Therapy for the treatment of symptomatic obstructive hypertrophic cardiomyopathy, a disorder characterized by abnormally thick heart muscle that compromises its pumping ability.
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.