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FDA Approves Urothelial Carcinoma Maintenance Treatment americanpharmaceuticalreview
July 13, 2020
The U.S. Food and Drug Administration (FDA) approved avelumab (BAVENCIO, EMD Serono) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) ...
EMA to consider expanding use of Merck/Pfizer's Bavencio pharmatimes
June 23, 2020
The European Medicines Agency has validated for review Merck and Pfizer's application to market Bavencio (avelumab) for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC).
EMD Serono, Pfizer Receive Breakthrough Therapy Designation, Submit Application for BAVENCIO americanpharmaceuticalreview
April 15, 2020
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer announced completion of the submission.
Balversa receives U.S. FDA approval for the treatment of patients with Urothelial Carcinoma biospectrumasia
April 16, 2019
The approval follows FDA Breakthrough Therapy Designation in March 2018 and Priority Review Designation of the New Drug Application submitted in September 2018.
Agilent Companion Diagnostic Gains Expanded FDA Approval in Urothelial Carcinoma americanpharmaceuticalreview
August 23, 2018
Agilent announced that the U.S. Food and Drug Administration (FDA) has approved its Dako PD-L1 IHC 22C3 pharmDx assay for expanded use in urothelial carcinoma.
Agilent’s Keytruda PD-L1 assay expanded in Europe to cover first-line urothelial carcinoma fiercebiotech
August 09, 2018
Agilent Technologies’ PD-L1 assay received an expanded label in Europe to help guide the use of first-line Keytruda in urothelial carcinoma. Physicians can now use the assay to help identify patients who are ineligible for cisplatin treatment and may resp
NICE turns down BMS' blockbuster Opdivo for urothelial carcinoma pharmafile
July 06, 2018
Just in time for the NHS’ 70th birthday, UK watchdog NICE has announced that it has taken the decision to reject Bristol-Myers Squibb’s blockbuster immunotherapy drug Opdivo (nivolumab) for use on the health service in the treatment of locally advanced un
Despite benefits, Merck's Keytruda falls short at NICE in urothelial carcinoma americanpharmaceuticalreview
August 07, 2017
In an initial review, cost watchdogs in England turned away Merck's Keytruda to treat urothelial carcinoma.
FDA Grants BAVENCIO(R) (avelumab) Approval for a Common Type of Advanced Bladder Cancer en-cphi.cn
May 10, 2017
Advanced urothelial carcinoma is an aggressive disease with a high rate of recurrence
FDA Grants Accelerated Approval to Bavencio (avelumab) for Urothelial Carcinoma drugs.com
May 10, 2017
The U.S. Food and Drug Administration granted accelerated approval to avelumab (Bavencio, EMD Serono, Inc.) for patients with locally advanced or metastatic urothelial carcinoma...