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.

FDA approves Bayer's finerenone to treat wide range of heart failure patients
Finerenone, sold by Bayer under the brand name Kerendia, is now approved in the United States for the treatment of HFmrEF and HFpEF. The drug has already been used for years to treat patients with chronic kidney disease and type 2 diabetes.
Statin use may protect patients from subarachnoid hemorrhages
Statins appear to be the most impactful for patients diagnosed with hypertension or cerebrovascular disease.
FDA grants breakthrough therapy designation to new drug candidate for FA cardiomyopathy
The new drug, LX2006, has already received the FDA's fast track designation. This latest distinction was based on early data from two separate clinical trials.
FDA finalizes new heart warnings for COVID-19 vaccines
The new warnings, first proposed to Pfizer and Moderna in April, are now officially required by the FDA. They provide additional information about the potential risks of myocarditis and/or pericarditis associated with these vaccines.
New report raises questions about data that helped heart drug gain FDA approval
Ticagrelor, an antiplatelet medication from AstraZeneca commonly prescribed by cardiologists, gained FDA approval back in 2011. The author of a new investigative report, however, is raising several concerns about the data used to secure that approval.

High copays keep many heart failure patients from filling needed prescriptions

Researchers examined data from more than 900 patients, presenting their findings in the Journal of the American Heart Association.

Regulatory Roundup: Updates on Medtronic and LivaNova recalls, FDA-cleared AI models, a new heart valve and more

Read our recap of some of the biggest FDA-related stories that impacted cardiology in the last month.

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FDA approves world’s most expensive drug, a hemophilia B treatment expected to cost $3.5M

The single-dose gene therapy can help patients reduce their risk of bleeding events and discontinue factor IX prophylaxis therapy.

ADHD medications and CVD: Lessons learned from a new meta-analysis of nearly 4 million patients

The new study, published in JAMA Network Open, should help ease any concerns patients may have about regularly taking ADHD medications.

Early catheter ablation superior to medication when treating ventricular tachycardia storm

VT storm is associated with a heightened risk of death or significant complications. Early catheter ablation, it seems, is the most effective treatment option for this potentially fatal condition.

OAC use among older AFib patients is on the rise

However, researchers noted, there is still considerable room for improvement.

FDA warns 7 companies for illegally selling dietary supplements that claim to treat CVD

The companies were given 15 days to provide an adequate response to the FDA's warning. The agency said its next step could include legal action.

Tracking the health benefits of influenza vaccines: ‘If you have heart failure, you should get your flu shot’

The new analysis focused on data from more than 5,000 heart failure patients throughout Asia, the Middle East and Africa.

Pharmaceutics

FDA approves Bayer's finerenone to treat wide range of heart failure patients

Statin use may protect patients from subarachnoid hemorrhages

FDA grants breakthrough therapy designation to new drug candidate for FA cardiomyopathy

FDA finalizes new heart warnings for COVID-19 vaccines

New report raises questions about data that helped heart drug gain FDA approval