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.
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.
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.
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.
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.
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.
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.
ImmunityBio resubmits FDA application for ANKTIVA in bladder cancer after agency requests updated efficacy data
ImmunityBio has resubmitted its supplemental biologics license application to the U.S. Food and Drug Administration for ANKTIVA (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guerin for BCG-unresponsive non-muscle invasive bladder cancer with papillary tumors, after the agency requested updated long-term efficacy data in March 2026. The resubmission follows a regulatory exchange that began in January […]
Why ImmunityBio’s ANKTIVA European launch could reshape BCG-unresponsive bladder cancer care
ImmunityBio expands ANKTIVA into Europe with Accord Healthcare. Discover what this means for bladder cancer care, regulation, and real-world adoption.
EMA backs ANKTIVA for bladder cancer: What it means for EU patients and future immunotherapies
ImmunityBio Inc. has received a positive recommendation from the European Medicines Agency for conditional marketing authorization of its immunotherapy ANKTIVA (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin for the treatment of BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ. The recommendation positions ANKTIVA as the first immunotherapy in the European Union for this indication, […]