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

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

Simply put, our ambition is to help more patients with prostate cancer. We are proud of the role NUBEQA currently plays in the treatment of ...

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

Bayer submits application to U.S. FDA for third indication of ...

Prostate cancer is the second most commonly diagnosed cancer in men1 and a key area of focus for Bayer. The company's franchise includes two ...

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

Bayer BAYRY announced the submission of a supplemental new drug application (sNDA) to the FDA for darolutamide.The sNDA is seeking approval of darolutamide, ...

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

BAYRY moves ahead with the submission of an application seeking approval of darolutamide in combination with androgen deprivation therapy in ...

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

Bayer is set to pursue a label expansion for Nubeqa (darolutamide) in a distinct subgroup of prostate cancer patients—those with metastatic ...

sNDA Filed With FDA for Darolutamide Plus ADT in mHSPC

... prostate cancer has been submitted to the FDA ... Bayer submits supplemental new drug application to U.S. FDA seeking expanded ...

Bayer submits sNDA to FDA for expanded indication for Nubeqa for ...

Bayer announced the submission of a supplemental new drug application to FDA for the oral androgen receptor inhibitor Nubeqa (darolutamide)

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

The company now plans to seek approval for the drug's use mHSPC indication sans additional chemotherapy. To that end, Bayer plans to submit the ...

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 ...

EU Approval Sought for Darolutamide Plus ADT for mHSPC - OncLive

The EMA has received a submission seeking the approval of darolutamide in combination with ADT in metastatic hormone-sensitive prostate cancer.

U.S. FDA approves additional indication of darolutamide in ... - Bayer

Darolutamide now has indications in both non-metastatic castration-resistant prostate cancer (nmCRPC) for men at high risk of developing metastatic disease ...

Bayer submits supplemental new drug application to USFDA ...

“Simply put, our ambition is to help more patients with prostate cancer,” said Christine Roth, Executive Vice President, Global Product Strategy ...

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

Home » News » Bayer Submits Application for Label Expansion of Prostate Cancer Drug. stocks. Bayer Submits Application for Label Expansion of Prostate ...

Bayer submits regulatory applications for oncology treatment ...

In the US, Bayer has filed for relapsed indolent B-cell non-Hodgkin's lymphoma (B-iNHL) / In the EU, Bayer has filed for relapsed marginal zone lymphoma ...

Bayer's Nubeqa one step closer to blockbuster status thanks to FDA ...

Already approved for early-stage disease, Bayer's label expansion bid centers on Nubeqa's use against metastatic hormone-sensitive prostate ...

Bayer | Pharmaceuticals on LinkedIn

BREAKINGNEWS: The U.S. FDA has approved an additional indication for our therapy to treat metastatic hormone-sensitive #ProstateCancer ...

Bayer submits EU marketing authorization application for ...

Bayer is continuing to submit applications for marketing authorizations of elinzanetant to further health authorities globally. ... The Phase III ...

FDA approves darolutamide tablets for metastatic hormone-sensitive ...

tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC). Efficacy was based on ...

U.S. Food and Drug Administration (FDA) accepts New Drug ... - Bayer

The New Drug Application (NDA) for elinzanetant, an investigational compound for the treatment of moderate to severe vasomotor symptoms ...