TCTMD

FDA Allows Claim About Oleic Acid’s Possible Heart Benefits on Labeling

The US Food and Drug Administration (FDA) will allow a new “qualified health claim” to be placed on the labels of oils with high levels of oleic acid, a monounsaturated fat, stating that consumption ...
FierceBiotech

FDA narrows label for Abiomed's Impella RP heart pump after mortality rose in post-approval study

After Abiomed’s attempts to expand the user pool for its Impella RP heart pump were less than successful, the FDA has updated the wording of the device’s label to direct it toward only the patients ...
FiercePharma

Delaware's Marlex Pharmaceuticals recalls 2 batches of heart failure drug after labeling mix-up

When it comes to heart failure medication, a labeling mix-up can have dire consequences. That's why Marlex Pharmaceuticals of New Castle, Delaware, is recalling two lots of digoxin tablets at the ...
Nasdaq

FDA Approves Labeling Update for Abbott's HeartMate 3 Heart Pump for use in Pediatric Patients

ABBOTT PARK, Ill., Dec. 17, 2020 /PRNewswire/ -- Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) has approved updated labeling for the company's HeartMate 3™ heart pump ...