Non-muscle Invasive Bladder Cancer

• CLINICAL_TRIALS approval · 2026-04-13
  Clinical Trial Update: Pre-Approval Expanded Access Study for TAR-200 Treating Physician Use

  TAR-200 has been approved for marketing for non-muscle invasive bladder cancer, and the update notes a pre-approval expanded-access program …

• EMA approval · 2025-12-12
  New medicine to treat non-muscle invasive bladder cancer

  The EMA announced approval of a new medicine, Anktiva (bempegaldesleukin), for non-muscle invasive bladder cancer that does not respond to B…

• FDA approval · 2025-09-09
  FDA Approved: INLEXZO — Original Application (Janssen Biotech, Inc)

  FDA approved INLEXZO, gemcitabine delivered intravesically, under Janssen’s original NDA for bladder cancer.

• FDA approval · 2025-06-12
  FDA Approved: ZUSDURI — Original Application (UroGen Pharma, Inc)

  FDA approves ZUSDURI (mitomycin) from UroGen Pharma under an original NDA, marking its first approval for use in bladder cancer.

• FDA approval · 2016-07-29
  FDA Approved: CYSVIEW — Supplemental Application (Photocure Inc.)

  The FDA has approved a supplemental application for CYSVIEW (HEXAMINOLEVULINATE HYDROCHLORIDE) from Photocure Inc.

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