Bristol’s Mavacamten Shows Consistent Efficacy, Safe Use In Obstructive HCM At ACC
US FDA Decision On First Indication Due On 28 April
Executive Summary
Long-term results from the EXPLORER-HCM extension study are consistent with the pivotal trial in obstructive hypertrophic cardiomyopathy, while data from VALOR may support a supplemental filing.
You may also be interested in...
Keeping Track: Mycovia Vivjoa, BMS Camzyos Approvals Bring FDA’s 2022 Novel Drug Tally To 12
US FDA closed out the month of April with two new molecular entity approvals that address underserved markets but carry some safety concerns.
BMS Does Not Think Pricing Or Monitoring Will Limit Camzyos Use
Bristol already is training cardiologists at major treatment centers in how to treat obstructive hypertrophic cardiomyopathy with Camzyos (mavacamten) based on the REMS in the US label.
Four Major Approval Decisions To Watch Out For In Q2
Having looked at four prominent drug candidates which are expecting important top-line data this quarter, with the help of Biomedtracker's Q2 Outlook Report, we take a look at four other assets that could soon break into the US market, from infectious diseases to diabetes.