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.   

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.

cardiologist doctor physician patient black diverse hypertension

FDA approves 3-in-1 polypill for hypertension

Widaplik, the new polypill from George Medicines, includes telmisartan, amlodipine and indapamide. The FDA's decision comes after positive data were published in both JACC and The Lancet.

Tom Price, MD, an orthopedic surgeon and former secretary of Health and Human Services (HHS) during the first Trump administration, says misinformation and growing distrust of healthcare workers and institutions is negatively impacting healthcare and more needs to be done to combat it.

Former HHS secretary says healthcare needs to fight back against medical misinformation

Tom Price, MD, an orthopedic surgeon and secretary of Health and Human Services (HHS) during the first Trump administration, says misinformation and growing distrust of healthcare workers and institutions is negatively impacting healthcare and more needs to be done to combat it.