PR Newswire

The newsfeed available here is provided by our content partner PR Newswire. This is one of the most important and widest-reaching press services, providing news, press releases and multimedia content to the media, journalists and the public.
The NewsWire Hub ("X-Billboard") currently comprises four of the most important international news sources and is supplemented by a stock market information service. The individual newswire services complement each other and provide a complementary range of information, more than three quarters of the official news sources on which editors worldwide base their stock market reporting. Your advantage: You will find everything here in one overview. You can navigate to the individual sections using the control elements. In the terminal view, you can carry out individual searches at company level.
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PR Newswire is an important news source that can be accessed via the X-Billboard. It is part of the Newswire Hub, which bundles important international news sources for stock market participants in one central location. If you want to get a quick overview, you can easily scroll through the headlines. If you want to look at the news in more detail, you can use the detailed views of the info cards to directly access the respective news item and other analysis tools.
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State: 17.08.2024 | 11PM
Wed, 15.01.2025       Johnson & Johnson
US4781601046

Application accepted for U.S. FDA Real-Time Oncology Review (RTOR) based on Phase 2b SunRISe-1 study showing highest single-agent complete response rate of 83.5 percent1

RARITAN, N.J., Jan. 15, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced it has initiated the submission of an original New Drug Application with the U.S. Food and Drug Administration (FDA) for TAR-200 for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. This submission is being reviewed by the FDA through the Real-Time Oncology Review (RTOR) program, which allows the FDA to review data before the complete application is formally submitted and helps ensure treatments are available for patients as soon as possible.

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