This expansion applies to the estimated 70 million patients who need either primary or secondary prevention, regardless of statin use. The FDA has approved label expansions for Esperion Therapeutics’ ...
ANN ARBOR, Mich., March 22, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that the United States Food and Drug Administration (FDA) has approved broad new label expansions for ...
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 ...
Bayer AG BAYRY announced that the FDA has approved a label expansion of kidney disease drug Kerendia (finerenone). The regulatory body approved finerenone for the treatment of adult patients with ...
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