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Bayer's sNDA for Kerendia Label Expansion Gets FDA's Priority Review
The FDA accepts and grants priority review to BAYRY's sNDA for Kerendia to treat patients with a common form of heart failure ...
Litigation, Debt, And Decline - Yet Bayer Seems Like A Buy
Bayer's 2024 annual results showed a 2.2% sales decline, with only free cash flow improving significantly. Read why BAYZF ...
Bayer Gets Speedy FDA Review of Kerendia in Heart Failure
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.
Nasdaq1d
Bayer's sNDA for Kerendia Label Expansion Gets FDA's Priority Review
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 ...
The Pharma Letter2d
FDA accepts Bayer’s sNDA for Kerendia for priority review
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 ...
Managed Healthcare Executive2d
FDA Grants Priority Review to Kerendia in Heart Failure
Regulators are expected to make a decision in the third quarter of 2025 on Kerendia to treat patients with heart failure with ...
Medical Dialogues3d
Bayer Finerenone secures USFDA Priority Review designation for heart failure
Berlin: Bayer has announced that the Company has received Priority Review designation from the U.S. Food and Drug ...