EMA Committee recommends marketing nod for Bayer advanced prostate cancer drug darolutamide Ruchika Sharma22 Jun 2025 1:00 PM ISTBerlin: Bayer has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has...
Bayer Prostate Cancer Drug Nubeqa gains third regulatory win from USFDA Ruchika Sharma4 Jun 2025 2:59 PM ISTBerlin: Bayer has received approval from the U.S. Food and Drug Administration (FDA) for its oral androgen receptor inhibitor (ARi) Nubeqa...
Bayer partner seeks approval for Darolutamide plus androgen deprivation therapy for metastatic hormone sensitive prostate cancer Ruchika Sharma8 Jan 2025 12:30 PM ISTOrion's collaboration partner Bayer has submitted an application to the Center of Drug Evaluation (CDE) of China's National Medical Products...
Bayer seeks EU nod to third indication of Darolutamide MD Bureau15 Oct 2024 12:29 PM ISTBerlin: Bayer said on Monday that it has applied to the EU's drugs regulator for the use of Nubeqa, also known as darolutamide, in combination with...
Bayer Pharma Gets CDSCO Panel Nod To Update Prescribing Information of Anti-cancer Drug Darolutamide Dr. Divya Colin1 July 2023 5:30 PM ISTNew Delhi: Bayer Pharma has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization...
Bayer gets EU approval for Nubeqa for additional indication in prostate cancer Ruchika Sharma5 March 2023 1:00 PM ISTNubeqa is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.
Bayer gets USFDA nod for Darolutamide, Docetaxel combo to treat metastatic hormone-sensitive prostate cancer Ruchika Sharma10 Aug 2022 3:00 PM ISTDarolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.
Bayer gets USFDA priority review for darolutamide plus docetaxel to treat metastatic hormone-sensitive prostate cancer Ruchika Sharma4 May 2022 12:00 PM ISTDarolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.
Bayer Submits Application for NUBEQA to USFDA and EMA MD Bureau12 March 2022 2:45 PM ISTBayer today announced the submission of a supplemental new drug application to the U.S. Food and Drug Administration USFDA as well as the submission...
Darolutamide increases survival in patients with metastatic, hormone-sensitive prostate cancer: NEJM Medha Baranwal12 March 2022 9:00 AM ISTUSA: Findings from a trial showed that the addition of darolutamide to androgen-deprivation therapy, and docetaxel increased overall survival in...
Darolutamide added to existing combination therapy in metastatic prostate cancer increases survival, NEJM says Medical Dialogues Editorial Team22 Feb 2022 9:00 AM ISTIn a new trial overall survival was remarkably longer with the combination of darolutamide, androgen-deprivation therapy, and docetaxel than with...
Bayer lifts peak sales estimate for prostate cancer drug Nubeqa : Report Ruchika Sharma18 Feb 2022 10:00 AM ISTFrankfurt: A therapy mix including Bayer's Nubeqa drug was shown to significantly prolong the lives of men suffering from metastatic prostate cancer...
