Bayer seeks Nubeqa label expansion after Phase III success

Bayer is advancing its efforts to expand the use of Nubeqa (darolutamide) for treating a specific group of prostate cancer patients who have ...

Bayer Submits Supplemental New Drug Application to U.S. FDA ...

Submission is based on positive results from the investigational pivotal Phase III ARANOTE trial that showed NUBEQA® (darolutamide) plus ...

Bayer eyes Nubeqa's label expansion in prostate cancer following ...

The Phase III trial evaluating Nubeqa in patients with metastatic hormone-sensitive prostate cancer met its primary endpoint.

Bayer eyes Nubeqa's label expansion in prostate cancer following ...

The Phase III trial evaluating Nubeqa in patients with metastatic hormone-sensitive prostate cancer met its primary endpoint.

sNDA Filed With FDA for Darolutamide Plus ADT in mHSPC

About the Phase 3 ARANOTE Trial · 1. Bayer submits supplemental new drug application to U.S. FDA seeking expanded indication for NUBEQA® ( ...

EU Approval Sought for Darolutamide Plus ADT for mHSPC - OncLive

... phase III ARANOTE trial. Ann Oncol. 2024;35(suppl 2):1-72 ... Bayer submits supplemental new drug application to U.S. FDA seeking expanded ...

ESMO 2024 Late-Breaking Data: Phase III ARANOTE Trial Shows ...

With these results, NUBEQA plus ADT now has demonstrated efficacy data in metastatic hormone-sensitive prostate cancer (mHSPC) both with and ...

Bayer proposes Nubeqa chemo-free regimen in prostate cancer type

Bayer plans to seek the FDA's blessing for Nubeqa plus androgen deprivation therapy (ADT) in mHSPC after the phase 3 ARANOTE trial showed ...

Finland's Orion eyes US sales boost with blockbuster prostate ...

Nubeqa, also known as darolutamide, is Bayer's third best ... following a successful phase III trial. Sign up here. Reporting by ...

Bayer Submits Application for Label Expansion of Prostate Cancer ...

The sNDA is seeking approval of darolutamide, in combination with androgen deprivation therapy (ADT), in patients with metastatic hormone-sensitive prostate ...

Bayer triples sales forecast for prostate cancer drug Nubeqa

The data will be filed with regulatory authorities to seek an expansion of the label ... after its drug candidate pimicotinib cleared a phase 3 tr.

Transcript Nubeqa Investor Webinar 2022-02-18 - Bayer

Last night, detailed study data of. ARASENS, our Phase 3 trial that examined the efficacy and safety of darolutamide to treat prostate cancer in ...

Bayer to seek label expansion for prostate cancer drug after late ...

Bayer (BAYRY) plans to seek expanded label for prostate cancer therapy Nubeqa after successful Phase 3 trial results. Read more here.

Bayer progressing well with transformation of pharma business and ...

Strong market uptake of Nubeqa™ and Kerendia™ / Asundexian projected peak sales of more than five billion euros as treatment option for ...

Bayer acquires Noria and PSMA Therapeutics to expand portfolio in ...

Broadens company's oncology platform of Targeted Alpha Therapies / Acquisition includes actinium-225 labeled differentiated PSMA small ...

Address by Board of Management - Bayer

Heike has been with us since last summer, so she may be familiar to some. And Julio is so new to the team that he's not even officially onboard ...

Darolutamide Plus ADT Significantly Improves Radiologic PFS in ...

Bayer announces positive topline results for NUBEQA (darolutamide) from phase III trial in men with metastatic hormone-sensitive prostate ...

Third quarter below prior year as expected – Group outlook confirmed

Bayer has confirmed its Group outlook for 2023 after posting third-quarter figures that were down against the previous year.

patent extension - Regulations.gov

Applicant hereby submits this application for extension of the patent term under. 35 U.S.C. § 156 by providing the following information ...

Bayer 2021: Overcoming obstacles - PharmaLive

We have successfully expanded the launch of our cancer drug Nubeqa and are continuously surpassing our own expectations. We have continued to ...