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 ...
Bayer’s Kerendia, already FDA approved in one cardiometabolic indication, now has data from a pivotal test that support expanding the drug’s label to heart failure. In preliminary results reported ...
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 ...