FDA extended the aficamten decision deadline to Dec. 26 after classifying the REMS submission as a major amendment to the NDA review.

The U.S. Food and Drug Administration (FDA) on Thursday extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application ... label and risk mitigation profile upon its ...

Unlocking the Potential of Atrioventricular Interval Modulation (AVIM) Therapy” will convene leading electrophysiologists, hypertension and heart failure specialists to discuss the unmet need in ...

It’s not as “perfect as they are selling it,” but it does avoid the more catastrophic complications of thermal ablation, says ...

Amiodarone also terminates AF, but its slow onset of action is an important disadvantage. The risk of pharmacological cardioversion is related to the proarrhythmic potential ... heart disease. w41 w42 ...

requires additional time to review a safety plan for its experimental heart drug, aficamten. The FDA has extended the Prescription Drug User Fee Act (PDUFA) action date to December 26, 2025, to fully ...

CAMZYOS reduces systolic contraction and can cause heart failure or significantly reduce ventricular function. Patients who experience a serious intercurrent illness (eg, serious infection) or ...

As this is needed for the fast upstroke of the action potential, LAs effectively inhibit impulse propagation and thus nociceptive (and other) signaling. The interplay between the LAs and the channel ...