Animedix

TAR-200 PDUFA Date (Johnson & Johnson)

FDA PDUFA decision date for TAR-200 is January 3, 2026. Developed by Johnson & Johnson. Indication: BCG-unresponsive high-risk non-muscle invasive bladder cancer. Current status: Approved.

Indication

BCG-unresponsive high-risk non-muscle invasive bladder cancer

Regulatory details

  • Company: Johnson & Johnson
  • Therapeutic area: Oncology / Urology
  • Application type: NDA
  • Review type: Priority
  • PDUFA date: 2026-01-03
  • Outcome: Approved