Camzyos Approved for Obstructive Hypertrophic Cardiomyopathy
Camzyos is an oral, selective allosteric and reversible inhibitor of cardiac myosin.
CHF and Arrhythmias
Mavacamten Evaluated in Patients With Obstructive Hypertrophic Cardiomyopathy Eligible for SRT
The VALOR-HCM trial evaluated the effects of mavacamten in over 100 patients with symptomatic obstructive HCM (NYHA class III-IV) who met the guideline criteria for SRT and had been referred for an invasive procedure.
Omecamtiv Mecarbil Under Review for Heart Failure With Reduced Ejection Fraction
The NDA is supported by data from the phase 3 GALACTIC-HF trial which included 8256 adults with heart failure with reduced ejection fraction,
Empagliflozin Gets Priority Review for Heart Failure Independent of LVEF
The application is supported by data from the phase 3 EMPEROR-Preserved trial.
CaroSpir, a Liquid Form of Spironolactone, Now Available in Unit Dose Cups
The new packaging allows for ease of administration and convenience.
FDA: Risk of LAAO Implant-Related Adverse Events May Be Higher for Women
The analysis included 49,357 patients undergoing LAAO procedures with the Watchman Left Atrial Appendage Closure device.
Empagliflozin Gets Breakthrough Tx Status for Heart Failure With Preserved Ejection Fraction
The designation is based on findings from the phase 3 EMPEROR-Preserved trial.
Empagliflozin Benefits Patients With Heart Failure and Preserved Ejection Fraction
The phase 3 EMPEROR-Preserved trial assessed empagliflozin in 5988 adults with heart failure with preserved ejection fraction, with and without diabetes.
Amplatzer Amulet Approved to Reduce Thromboembolic Risk in Atrial Fibrillation
The Amulet device is designed for complete immediate closure of the left atrial appendage using dual-seal technology.
Sodium Bicarbonate Injection Recalled Due to Microbial Contamination
According to the Company, intravenous administration of the affected product could lead to “site specific infections as well as serious systemic infections which may be life-threatening.”
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