Zacks Investment Research on MSN11d
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 ...
Managed Healthcare Executive12d
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 ...
MarketWatch12d
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. Bayer on ...
Yahoo Finance11d
Bayer's sNDA for Kerendia Label Expansion Gets FDA's Priority Review
The priority review from the FDA usually brings down the review period to six months, compared to the standard review time of 10 months. We note that finerenone is already marketed as Kerendia or ...