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.   

Bayer finerenone Kerendia heart failure MOONRAKER

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.

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Statin use may protect patients from subarachnoid hemorrhages

Statins appear to be the most impactful for patients diagnosed with hypertension or cerebrovascular disease.

heart drugs with stethoscope

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.

pharmaceutical drug approval process

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.

Popular obesity drugs limit amputations, heart issues among patients with peripheral artery disease

Semaglutide, tirzepatide and other GLP-1 drugs appear to provide significant value for patients with moderate PAD.

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Updated: Dexcom recalls more than 700K CGM receivers over safety issues—dozens of adverse events reported

There is an increased risk that these devices will not provide audible alerts for low or high blood glucose levels. The FDA has ruled that this is a Class I recall, highlighting the safety risks associated with missed alerts.

merger acquisition M&A business

Eli Lilly to acquire gene-editing specialists focused on CVD for up to $1.3B

The company has agreed to acquire Verve Therapeutics for an upfront payment of approximately $1 billion. The total could increase significantly, however, if certain milestones are met. One of Verve's biggest gene therapies has already received the FDA's fast track designation.