You are here: Industry Insights > urothelial cancer

News List

Japan's Ministry of Health, Labour and Welfare Grants Priority Review for Enfortumab Vedotin NDA americanpharmaceuticalreview
May 17, 2021
Astellas Pharma Inc. announced Japan's Ministry of Health, Labour and Welfare (MHLW) has granted priority review for the company's New Drug Application (NDA), which was submitted in March.
Astellas, Seagen Submit sBLAs for PADCEV for Urothelial Cancer americanpharmaceuticalreview
February 24, 2021
Astellas Pharma and Seagen announced completion of submissions for two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for PADCEV® (enfortumab vedotin-ejfv).
Astellas, Seagen Announce PADCEV Trial Results for Urothelial Cancer americanpharmaceuticalreview
February 18, 2021
Astellas Pharma and Seagen announced primary results from the phase 3 EV-301 trial comparing PADCEV® (enfortumab vedotin-ejfv) to chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with ...
Everest Medicines Announces CTA Approval by China NMPA for Phase 3 Trial of Sacituzumab Govitecan-Hziy for Metastatic Urothelial Cancer prnasia
January 07, 2021
Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, announced that the Center ...
Astellas, Seagen Announce Positive Results from PADCEV Trial for Urothelial Cancer americanpharmaceuticalreview
October 16, 2020
Astellas Pharma and Seagen announced positive topline results from the second cohort of patients in the pivotal phase 2 single-arm clinical trial known as EV-201.
PADCEV succeeds in confirmatory phase 3 trial in urothelial cancer pharmaceutical-business-review
September 23, 2020
Seattle Genetics and Astellas Pharma said that PADCEV (enfortumab vedotin-ejfv) met the primary endpoint of overall survival (OS) in a confirmatory phase 3 trial in previously treated locally advanced or metastatic urothelial cancer.
Infinity gets FDA fast track status for IPI-549, Opdivo combo in urothelial cancer pharmaceutical-business-review
March 30, 2020
Infinity Pharmaceuticals said that IPI-549 in combination with nivolumab (Opdivo) has been given the fast track designation from the US Food and Drug Administration (FDA).
NICE hits Keytruda with ‘no’ for urothelial cancer pharmatimes
March 13, 2020
The National Institute for Health and Care Excellence (NICE) has published a new final draft guidance recommending against the routine use of Keytruda (pembrolizumab) locally advanced or metastatic urothelial carcinoma.
FDA Approves Padcev (enfortumab vedotin-ejfv) for Locally Advanced or Metastatic Urothelial Cancer, the Most Common Type of Bladder Cancer drugs
December 20, 2019
Astellas Pharma Inc. and Seattle Genetics, Inc. (Nasdaq:SGEN) announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Padcev™ for the treatment of ...
UroGen’s urothelial cancer drug hits target, could prevent surgery pharmaphorum
January 10, 2019
Former Novartis oncology chief Liz Barrett’s decision to jump ship to lead the biotech UroGen appears to have been vindicated after the company announced top-line results showing its lead drug could change standard of care in a form of urothelial cancer.

Previous page 1 2 Next page