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non-muscle invasive bladder cancer

PharmaDeviceNews non-muscle invasive bladder cancer
Pharma & Biotech

Tyra Biosciences SURF302 data put dabogratinib’s oral bladder cancer strategy under scrutiny

Tyra Biosciences’ dabogratinib showed encouraging single-lesion responses in SURF302, but mixed broader data sent shares sharply lower.

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Representative image: Endoscopic bladder procedure scene highlighting UroGen Pharma’s UGN-501 clearance and the next-stage search for intravesical oncolytic virus therapy in non-muscle invasive bladder cancer.
Pharma & Biotech

Could UroGen Pharma’s oncolytic virus open the next chapter in bladder cancer therapy?

UroGen Pharma Ltd. (Nasdaq: URGN) has received U.S. Food and Drug Administration clearance of its Investigational New Drug application for UGN-501, an investigational next-generation oncolytic virus for non-muscle invasive bladder cancer. The clearance enables the urothelial cancer-focused biotechnology company to begin a planned Phase 1 trial of local intravesical administration, with patient enrollment expected to

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Pharma & Biotech

UroGen Pharma has FDA clearance for UGN-501, but can an oncolytic virus work in bladder cancer?

Find out how UroGen Pharma’s UGN-501 could test oncolytic virus therapy for recurrent non-muscle invasive bladder cancer.

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Pharma & Biotech

Papillary NMIBC could become the next commercial test for ImmunityBio’s ANKTIVA franchise

ANKTIVA already has an NMIBC foothold. The harder test is whether FDA reviewers accept extrapolation into papillary-only disease.

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Representative image: A clinician reviews bladder imaging during a urology consultation, reflecting Ferring Pharmaceuticals’ ADSTILADRIN re-induction data and the growing focus on bladder-sparing treatment strategies for BCG-unresponsive non-muscle invasive bladder cancer.
Pharma & Biotech

Can Ferring turn real-world ADSTILADRIN use into a broader NMIBC treatment strategy?

Bladder-sparing therapy needs better sequencing. Ferring’s ADSTILADRIN re-induction signal raises hope, but durability is the real test.

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Representative image of clinical research vials and bladder cancer diagnostics, reflecting ImmunityBio’s Tokyo-172 BCG agreement with Japan BCG Laboratory and its potential role in easing the long-running U.S. BCG supply shortage for non-muscle invasive bladder cancer treatment.
Pharma & Biotech

Why ImmunityBio’s Japan BCG Laboratory agreement matters beyond bladder cancer supply

A bladder cancer supply crisis meets fresh Phase III data. ImmunityBio’s Tokyo BCG deal could test how flexible U.S. regulators are willing to be.

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Representative image: AI-powered digital pathology analysis for bladder cancer risk testing, highlighting how Valar Labs’ Vesta Bladder Risk Stratify Dx could support more precise non-muscle invasive bladder cancer prognosis after receiving FDA Breakthrough Device Designation.
Medical Devices & Diagnostics

Valar Labs FDA breakthrough nod signals new test for AI-led bladder cancer risk prediction

Bladder cancer risk tools leave gray zones. Valar Labs’ FDA breakthrough nod tests whether AI pathology can narrow them.

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Pharma & Biotech

Can Forlong Biotechnology’s FL115 poster at ASCO 2026 move the IL-15 story from scientific promise toward clinical relevance?

Forlong Biotechnology brings FL115 to ASCO 2026 with first-in-human solid tumor data. Read why the IL-15 story could matter beyond the poster.

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Representative image of vial thawing in a clinical preparation setting, illustrating how Ferring Pharmaceuticals’ faster ADSTILADRIN thaw protocol could improve bladder cancer treatment workflow in BCG-unresponsive non-muscle invasive bladder cancer.
Pharma & Biotech

Ferring wins ADSTILADRIN label update as operational efficiency becomes a bigger oncology battleground

FDA clears faster ADSTILADRIN thawing for bladder cancer care. Read why this workflow update could matter for NMIBC adoption and treatment strategy.

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Pharma & Biotech

Macau clears ImmunityBio’s ANKTIVA for BCG-unresponsive NMIBC, opening Asia market amid commercialization test

ImmunityBio's first Asia approval for ANKTIVA in BCG-unresponsive bladder cancer: what the Macau clearance means for its global strategy. Read the analysis.

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