TAR-200, Bladder Cancer and carcinoma in situ
Johnson & Johnson Initiates New Drug Application for TAR-200 in BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer
The New Drug Application for TAR-200 is supported by results from the Phase IIb SunRISe-1 study, which demonstrated an 83.5% complete response in patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer.
J&J Initiates Bid for FDA Approval of TAR-200 in Bladder Cancer
The New Brunswick, N.J., pharmaceutical giant said the FDA accepted the application through its Real-Time Oncology Review program, which allows for an earlier submission of topline efficacy and safety study results prior to the submission of a complete application to support an earlier start to the agency's review.
Johnson & Johnson Initiates IND Submission Of TAR-200 To Treat High-risk Bladder Cancer
(RTTNews) - Johnson & Johnson (JNJ) Wednesday said it has initiated the submission of new drug application or NDA to Food and Drug Administration (FDA) for TAR-200 to treat patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
An FDA application for TAR-200 to treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer is under real-time ...
A phase 3 trial of Johnson & Johnson's TAR-200 therapy in bladder cancer has failed to show efficacy, although the company is still confident in the potential of the programme. The SunRISe-2 ...
Johnson & Johnson announced it has initiated the submission of an original New Drug Application with the U.S. FDA for TAR-200 for the ...
The pharma began submitting its TAR-200 bladder cancer treatment to the FDA. Elsewhere, Sarepta and Madrigal reported strong ...
A phase 3 trial of Johnson & Johnson's TAR-200 therapy in bladder cancer has failed to show efficacy, although the company is still confident in the potential of the programme. AstraZeneca has ...
The Food and Drug Administration is banning the use of Red No. 3, an artificial dye linked to cancer in animals, from food and ingested drugs. Johnson & Johnson initiated an application seeking Food ...
CG Oncology's stock has dropped 40% since its IPO peak, driven by profit-taking and competitive concerns despite promising ...
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