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Bayer's sNDA for Kerendia Label Expansion Gets FDA's Priority ReviewBayer AG BAYRY recently announced that the FDA had accepted its supplemental new drug application (sNDA) seeking approval for ...
Regulators are expected to make a decision in the third quarter of 2025 on Kerendia to treat patients with heart failure with ...
Bayer has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its kidney-disease drug Kerendia in certain people with heart failure.
Bayer's mineralocorticoid receptor antagonist (MRA) Kerendia hit the mark as a treatment for a common form of heart failure in the FINEARTS-HF study, setting up regulatory approvals, but there is ...
The US Food and Drug Administration (FDA) accepted and granted Priority Review designation for Bayer’s (BAYN: DE) supplemental new drug application (sNDA) for a new indication for Kerendia (finerenone ...
Kerendia sales surged 62%, mainly due to a substantial rise in volumes in the United States and business expansion in China. However, sales of oral anticoagulant Xarelto, co-developed with J&J JNJ ...
Bayer has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its kidney-disease drug Kerendia in certain people with heart failure. Drug giant ...
Bayer has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its kidney-disease drug Kerendia in certain people with heart failure. Bayer on ...
Bayer AG BAYRY recently announced that the FDA had accepted its supplemental new drug application (sNDA) seeking approval for Kerendia (finerenone) to treat a new indication. The sNDA seeks ...
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