Pharmaceutics

This page contains key pharmaceutical news on drug recalls, FDA clearance, safety communications and research. In cardiology, key pharmaceutic agents include antiplatelet therapies, anticoagulants, hypertension drugs, and drugs for heart failure and arrhythmias.   

pharmaceutical drug approval process

Mavacamten fails to boost outcomes for patients with nonobstructive HCM

The drug, already approved by the FDA to treat obstructive HCM, failed to outperform a placebo after 48 weeks.

Semaglutide tops dulaglutide when treating patients with type 2 diabetes and CVD

Researchers tracked real-world data from nearly 60,000 Medicare patients, highlighting the benefits of weekly injections of semaglutide. 

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Oral semaglutide linked to significant weight loss as Novo Nordisk awaits FDA approval

An oral version of the popular GLP-1 drug was associated with multiple benefits, including considerable improvements in BMI and waist circumference. Previous research found that it reduces certain heart risks in patients with type 2 diabetes.

Corstasis Therapeutics bumetanide nasal spray Enbumyst

FDA approves nasal spray for edema associated with congestive heart failure

The newly approved intranasal loop diuretic can also be used to treat edema in patients with liver and kidney disease.

The Dexcom G7 Continuous Glucose Monitoring System

Dexcom issues new recall for CGM apps due to safety risk—users urged to update immediately

The FDA has categorized this as a Class I recall. If patients update their phone or watch apps as needed, they can continue to use these devices like normal.

COVID-19 vaccine vaccination myocarditis heart damage inflammation RSNA imaging radiology cardiology

Why all heart patients should be vaccinated against the flu, COVID-19, RSV

The American College of Cardiology has shared new recommendations highlighting the protective benefits of a variety of vaccines. The new guidance also examines how to speak with patients who are hesitant to be vaccinated. 

Joshua M. Hare, MD, FACC, FAHA, a professor of medicine, molecular and cellular pharmacology, and biomedical engineering, director of regenerative medicine, and director of the Interdisciplinary Stem Cell Institute (ISCI) at the University of Miami, and co-founder and chief science officer for the stem cell start-up Longeveron, explains the FDA trial for laromestrocel (Lomecel-B) to treat hypoplastic left heart syndrome (HLHS).

First study of its kind to focus on new therapy for hypoplastic left heart syndrome

The new trial represents a potential breakthrough in the treatment of one of the most devastating congenital heart defects.

Real-world data link semaglutide, tirzepatide to improved heart failure outcomes

GLP-1 drugs have been taking the United States by storm in recent years. According to a new study of more than 90,000 patients, some of these medications can also make a big impact on reducing adverse heart failure outcomes.