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Mashup Score: 2FDA Clears NMIBC Agent TYRA-300 for Phase 2 Trial - 8 hour(s) ago
TYRA-300 has gained an investigational new drug application from the FDA and will be further studied in the phase 2 SURF302 trial for patients with low-grade, intermediate-risk non–muscle-invasive bladder cancer.
Source: www.targetedonc.comCategories: General Medicine News, Oncologists1Tweet
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Mashup Score: 4
A Prescription Drug User Fee Act target action date of June 13, 2025, has been set for the new drug application of intravesical mitomycin.
Source: www.targetedonc.comCategories: General Medicine News, Oncologists1Tweet-
The #FDA has accepted the new drug application of intravesical mitomycin for the treatment of low-grade, intermediate-risk non–muscle-invasive bladder cancer. #NMIBC #BLCSM https://t.co/OeZ7L4n2vj
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Mashup Score: 0FDA Accepts IND for UGN-103 in Low-Grade Intermediate-Risk NMIBC - 9 month(s) ago
An investigational new drug application for UGN-103 was accepted by the FDA. A phase 3 study to assess the safety and efficacy of the agent in low-grade intermediate-risk non-muscle invasive bladder cancer is anticipated.
Source: www.targetedonc.comCategories: General Medicine News, Onc News and JournalsTweet-
The #FDA has accepted the investigational new drug application for UGN-103 for the treatment of low-grade intermediate-risk #NMIBC. #BLCSM https://t.co/AXCdHG8E2X
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Mashup Score: 0
The gene therapy, nadofaragene firadenovec-vncg, is now fully available across the United States for patients with this aggressive bladder cancer.
Source: www.targetedonc.comCategories: General Medicine News, Onc News and JournalsTweet-
Nadofaragene firadenovec is the first and only intravesical gene therapy to be approved by the #FDA for adult patients with #NMIBC who no longer respond to standard therapy. #BLCSM https://t.co/LwXsGeC12G https://t.co/YZhjrWNoV8
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Mashup Score: 1
With an investigational new drug granted to ZH9 by the FDA, a clinical development program for the treatment of patients with non-muscle invasive bladder cancer can be initiated.
Source: www.targetedonc.comCategories: General Medicine News, Onc News and JournalsTweet-
The #FDA has granted an investigational new drug application to the immunotherapy ZH9, which will be developed for patients with #NMIBC. #blcsm https://t.co/ukxnoCTLn2
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The #FDA has cleared the IND application for TYRA-300, an oral FGFR3-selective inhibitor, for use in low-grade, intermediate-risk #NMIBC. This regulatory decision paves the way for a phase 2 clinical trial of TYRA-300 in this patient population. #blcsm https://t.co/QVqnu6fkx7