Tag: Bristol-Myers Squibb

Bristol Myers Squibb Showcases the Continued Strength of its Cardiovascular Portfolio with New Clinical and Real-World Data at American Heart Association Scientific Sessions 2024

Real-world and long-term extension data, including updated results from post-launch evaluation of REMS Program, bolster growing body of evidence supporting the efficacy and safety profile of CAMZYOS ® (mavacamten) PRINCETON, N.J.–(BUSINESS WIRE)– Bristol Myers Squibb (NYSE: BMY) today announced the presentation of data across its […]

Bristol Myers Squibb to Present Data at the American College of Cardiology Annual Scientific Session 2024 Reinforcing Extensive Body of Evidence in Clinical and Real-World Settings Across Cardiovascular Portfolio

Analysis from a 10-month post-launch evaluation of the REMS Program finds 2.8% incidence of LVEF <50% in over 1500 patients, strengthening the safety profile of CAMZYOS® (mavacamten) for NYHA class II-III obstructive hypertrophic cardiomyopathy Real-world data reaffirm therapeutic value and treatment benefit of CAMZYOS in […]

Bristol Myers Squibb Receives European Commission Approval of CAMZYOS® (mavacamten), for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy (HCM)

CAMZYOS is the first and only cardiac myosin inhibitor approved in the European Union Approval based on two positive Phase 3 trials, EXPLORER-HCM and VALOR-HCM, demonstrating significant benefit in patients treated with CAMZYOS versus placebo PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that […]

U.S. Food and Drug Administration Approves Addition of Positive Data from Phase 3 VALOR-HCM Study to CAMZYOS® (mavacamten) Label

CAMZYOS is the first and only FDA-approved cardiac myosin inhibitor that specifically targets the underlying source of obstructive HCM VALOR-HCM is the second Phase 3 trial in which CAMZYOS demonstrated significant improvement in symptoms of obstructive HCM June 15, 2023 08:23 PM Eastern […]

Viz.ai Announces Agreement with Bristol Myers Squibb to Enable Earlier Detection and Management of Suspected Hypertrophic Cardiomyopathy (HCM)

Viz.ai has submitted a de novo classification request to the FDA for a new AI algorithm intended to identify and triage patients suspected with HCM SAN FRANCISCO–(BUSINESS WIRE)–Viz.ai, a leader in AI-powered disease detection and care coordination, today announced a multi-year agreement […]

Bristol Myers Squibb to Present Data Supporting its Cardiovascular Portfolio at the American College of Cardiology Annual Scientific Session Together With World Congress of Cardiology

Data across EXPLORER-HCM, MAVA-LTE and PIONEER-OLE add to the growing body of evidence from the CAMZYOS® (mavacamten) development program, reinforcing the therapeutic value and benefit to patients PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced the presentation of research supporting […]

U.S. Food and Drug Administration (FDA) Accepts Supplemental New Drug Application for CAMZYOS® (mavacamten) in Symptomatic Obstructive Hypertrophic Cardiomyopathy to Reduce the Need for Septal Reduction Therapy

U.S. FDA has assigned a target action date of June 16, 2023 Application based on results from the Phase 3 VALOR-HCM study PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted […]