FDA approves supplemental new drug application to expand Mavacamten label for hypertrophic obstructive cardiomyopathy
The FDA has approved a supplemental new drug application (sNDA) to expand the label on mavacamten (Camzyos) to include data from the Phase 3 VALOR HCM study. The study evaluated mavacamten in patients with symptomatic hypertrophic obstructive cardiomyopathy (HCM) eligible for septal reduction therapy (SRT) and with New York Heart Association (NYHA) Class 3-4 or … Read more