Following discussions with the U.S. FDA, the Agency recommended that the Company submit additional information for its evaluation of this information to potentially support a resubmission of the sBLA ...

SAN FRANCISCO -- Neoadjuvant chemoimmunotherapy for muscle-invasive bladder cancer (MIBC) followed by risk-adapted therapy led to high rates of metastasis-free survival (MFS) and bladder preservation, ...

CG Oncology has announced that topline data from its Phase 3 PIVOT-006 trial of intravesical cretostimogene grenadenorepvec ...

Shares of ImmunityBio IBRX surged 17.4% after it announced a recent face-to-face meeting with senior FDA officials to align ...

An update from the phase 2 LEGEND trial shows that the investigational nonviral gene therapy detalimogene voraplasmid has achieved a 62% complete response rate at six months in patients with high-risk ...

(StatePoint) The bladder cancer treatment landscape is rapidly evolving, particularly for patients who don’t respond to bacillus Calmette–Guérin (BCG), the most common intravesical immunotherapy for ...

Overall survival appears no worse for patients with organ-confined limited-stage small cell bladder cancer receiving multimodal organ-preserving treatment. For patients with limited-stage small-cell ...

Radical cystectomy continues to have an important role in the management of recurrent high-grade NMIBC, according to results from the CISTO study. The CISTO study assessed patient-important outcomes ...

"The next decade will witness an unprecedented convergence of powerful therapeutics, precise biomarkers, and personalized strategies creating a watershed moment to redefine muscle-invasive bladder ...

– 74.5% of patients achieved a complete response at any time – – Median duration of response is greater than 27 months and not reached – – Latest data update continued to show favorable safety and ...