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FDA grants priority review for new indication of finerenone for patients with heart failure and with a left ventricular ejection fraction of ≥40% – Bayer

Written by | 20 Jul 2025

Bayer announced that the FDA has accepted its supplemental New Drug Application (sNDA) and granted Priority Review designation for finerenone for the treatment of adult patients with heart… read more.

Bayer files for approval of finerenone in heart failure in Japan

Written by | 18 Feb 2025

Bayer announced the submission of a marketing authorization application to the Ministry of Health, Labour, and Welfare (MHLW) in Japan, seeking approval of finerenone in adult patients with… read more.

Bayer files for approval of finerenone in heart failure in the EU

Written by | 7 Feb 2025

Bayer announced the submission of a marketing authorization application to the EMA, seeking approval in the EU for the use of finerenone in adult patients with HF with… read more.

Bayer submits application to the FDA and to China’s CDE for new indication of finerenone for patients with common form of heart failure with high unmet medical need

Written by | 20 Jan 2025

Bayer announced the submission of marketing authorization applications to the FDA and to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), seeking approval… read more.

Bayer to present comprehensive findings on Finerenone from FINEARTS-HF trial at CVCT 2024

Written by | 11 Dec 2024

Bayer announced that new analyses from the Phase III FINEARTS-HF trial evaluating finerenone (Kerendia) in patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of… read more.

Finerenone showed statistically significant improvement in cardiovascular outcomes in adults with common form of heart failure with high unmet medical need – Bayer

Written by | 8 Sep 2024

Detailed results from the Phase III study FINEARTS-HF demonstrate that compared to placebo, finerenone (Kerendia/ Firialta) showed a statistically significant improvement in cardiovascular outcomes in patients with heart… read more.

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