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 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 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 has filed an application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for marketing authorization of the oral androgen receptor inhibitor… read more.
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.
Bayer announced that the FDA has accepted the company’s supplemental new drug application (sNDA) for the oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) in combination with androgen deprivation… read more.
Bayer announced 510(k) clearance from the FDA for its Medrad Centargo CT Injection System, an innovative multi-patient injector that drives workflow efficiency with design features that integrate with… read more.
Bayer and its collaboration partner Regeneron presented results from the open-label extension study of the clinical trial PHOTON in patients with diabetic macular edema (DME) at three years,… read more.
Bayer announced the submission of an application to the European Medicines Agency (EMA) for the oral androgen receptor inhibitor (ARi) darolutamide. Bayer is seeking approval for the use… read more.
The European Medicines Agency (EMA) has approved the pre-filled syringe for the administration of Eylea™ 8 mg (114.3 mg/ml solution for injection) in the European Union. The new… read more.
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.
The Phase III ARANOTE trial, investigating darolutamide plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC), has met its primary endpoint of rPFS.( radiological progression-free survival). Darolutamide… read more.
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