An innovative new treatment option for bladder cancer, recently approved by the U.S. Food and Drug Administration, has been performed for the first time in Maryland.

On Sept. 5, 2025, the U.S. Food and Drug Administration (FDA) approved Inlexzo (gemcitabine intravesical system) for adults ...

Announces NDV-01 9-Month Follow-up Safety and Efficacy Data in NMIBC FDA feedback supports 2 potential registrational trials – 1) a ...

First and only drug releasing system to provide extended local delivery of a cancer medication into the bladder, with 82 percent of patients achieving complete response without the need for ...

Credit: J&J. The New Drug Application is supported by data from cohort 2 of the single-arm, phase 2b SunRISe-1 study. The device remains in the bladder and provides a sustained release of gemcitabine ...

The FDA approved a gemcitabine intravesical system (Inlexzo) for adults with non-muscle-invasive bladder cancer (NMIBC), the agency announced on Tuesday. The indication for the chemotherapy-containing ...

Credit: Johnson & Johnson. Inlexzo is supplied as a single-dose intravesical system containing 225mg of gemcitabine plus a sterile urinary catheter and stylet. Inlexzo is an intravesical gemcitabine ...

The FDA has approved a gemcitabine intravesical system for Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), either with or without ...

Less than two months after receiving priority review status for an NDA, Johnson & Johnson won U.S. FDA approval of Inlexzo, its intravesical gemcitabine-releasing system previously known as TAR-200, ...

Please provide your email address to receive an email when new articles are posted on . Most patients with non-muscle-invasive bladder cancer who received TAR-200 with gemcitabine achieved complete ...

Bladder Cancer Awareness Month highlights the importance of early detection and support for patients, emphasizing the disease's prevalence and potential fatality. Treatment strategies differ by ...