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Supplemental approval of Opdivo + cisplatin + gemcitabine for treatment of unresectable urothelial carcinoma in Japan – Ono Pharma

Written by | 4 Jan 2025

Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb K.K.  announced that Ono has received a supplemental approval of Opdivo (generic name: nivolumab) Intravenous Infusion (“Opdivo”), an anti-PD-1 antibody, in… read more.

CG Oncology to present latest data on Cretostimogene Grenadenorepvec at SUO 2024 annual meeting

Written by | 23 Nov 2024

CG Oncology, Inc, a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced that four Trials… read more.

Gilead Sciences to withdraw Trodelvy (sacituzumab govitecan-hziy) for bladder cancer in the US

Written by | 25 Oct 2024

After falling short in a confirmatory clinical trial, Gilead Sciences has decided to withdraw Trodelvy (sacituzumab goviteca-hziy) as a bladder cancer treatment in the U.S. Gilead Sciences announced… read more.

FDA approval sought for UGN 102 in low-grade, intermediate-risk, non–muscle-invasive, bladder cancer – Urogen Pharma

Written by | 22 Aug 2024

A new drug application (NDA) has been submitted to the FDA seeking the approval of mitomycin for intravesical solution (UGN 102) for the treatment of patients with low-grade,… read more.

European Commission approves Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma – BMS

Written by | 23 Jun 2024

Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable… read more.

FDA approves Anktiva, (N-803, or nogapendekin alfa inbakicept-pmln) first-in-class IL-15 receptor agonist for BCG-unresponsive non-muscle invasive bladder cancer – ImmunityBio

Written by | 6 May 2024

ImmunityBio, Inc. an immunotherapy company, announced that the FDA has approved Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive… read more.

FDA approves Opdivo (nivolumab), plus cisplatin and gemcitabine, for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma – BMS

Written by | 17 Mar 2024

Bristol Myers Squibb announced that the FDA approved Opdivo (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial… read more.

FGFR inhibitor erdafitinib for urothelial cancer is filed in Japan – Janssen Pharmaceutical

Written by | 1 Dec 2023

Janssen Pharmaceutical has filed a new drug application in Japan for its oral fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor erdafitinib for the treatment of certain patients… read more.

Keytruda (pembrolizumab) met a primary endpoint of disease-free survival in certain patients with muscle-invasive urothelial carcinoma after surgery – Merck Inc

Written by | 16 Oct 2023

Merck Inc., known as MSD outside of the United States and Canada, announced that the Phase III AMBASSADOR (A031501) trial (KEYNOTE-123) evaluating Keytruda, Merck’s anti-PD-1 therapy, met one… read more.

Padcev and Keytruda significantly improve overall survival and progression-free survival in previously untreated advanced bladder cancer in pivotal phase III EV-302 trial – Seagen + Astellas

Written by | 5 Oct 2023

Seagen Inc. and Astellas Pharma Inc. announced positive topline results from the Phase III EV-302 clinical trial (also known as KEYNOTE-A39) for Padcev (enfortumab vedotin-ejfv) in combination with… read more.

MAA is submitted to the European Medicines Agency seeking approval of erdafitinib for the treatment of patients with locally advanced or metastatic urothelial cancer with susceptible FGFR alterations – Janssen Pharmaceutical

Written by | 17 Sep 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of erdafitinib for… read more.

First-line Opdivo plus chemotherapy provides survival benefit in metastatic urothelial carcinoma (bladder cancer) – BMS

Written by | 24 Jul 2023

Frontline treatment with the combination of nivolumab (Opdivo) and cisplatin-based chemotherapy, followed by nivolumab monotherapy, led to a statistically significant improvement in progression-free survival (PFS) and overall survival… read more.

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