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Results For "Christine-Roth"

7 News Found

USFDA grants Priority Review for new indication of finerenone for patients with common heart failure
Drug Approval | March 20, 2025

USFDA grants Priority Review for new indication of finerenone for patients with common heart failure

Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure


Bayer files for approval of finerenone in heart failure in Japan
News | February 15, 2025

Bayer files for approval of finerenone in heart failure in Japan

Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure


Acoramidis receives positive CHMP opinion for treatment of transthyretin amyloid cardiomyopathy
Drug Approval | December 14, 2024

Acoramidis receives positive CHMP opinion for treatment of transthyretin amyloid cardiomyopathy

Final decision from the European Commission is anticipated within the coming months


Long-term efficacy and safety profile of Eylea 8 mg with extended dosing intervals in diabetic macular edema confirmed at three years
News | October 19, 2024

Long-term efficacy and safety profile of Eylea 8 mg with extended dosing intervals in diabetic macular edema confirmed at three years

Results from the open-label extension study of PHOTON demonstrate patients with diabetic macular edema (DME) randomized to Eylea 8 mg maintained visual and anatomic improvements at the end of three years


Bayer submits supplemental new drug application to USFDA seeking expanded indication for NUBEQA
Drug Approval | September 29, 2024

Bayer submits supplemental new drug application to USFDA seeking expanded indication for NUBEQA

NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC)


Bayer submits NDA to USFDA for elinzanetant for the treatment of VMS associated with menopause
Drug Approval | August 01, 2024

Bayer submits NDA to USFDA for elinzanetant for the treatment of VMS associated with menopause

The New Drug Application (NDA) includes data from the Phase III studies OASIS 1, 2 and 3 - showing elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms over 12 weeks compared to placebo


CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer
Drug Approval | January 31, 2023

CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer

CHMP recommendation is based on Phase III data, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5%