Tags : Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

Regulatory

BMS Reports the US FDA’s Acceptance of NDA for Mavacamten

Shots: The NDA submission is based on results from the P-III EXPLORER-HCM trial involves assessing Mavacamten vs PBO in 251 patients with symptomatic oHCM. The FDA has anticipated a PDUFA date of January 28, 2022 The P-III EXPLORER-HCM trial results demonstrated the robust treatment effect, with patient responses to treatment, including reductions in symptoms, functional […]Read More