Animedix

Darzalex Faspro (D-VRd) PDUFA Date (Johnson & Johnson)

FDA PDUFA decision date for Darzalex Faspro (D-VRd) is January 27, 2026. Developed by Johnson & Johnson. Indication: Newly diagnosed multiple myeloma (transplant eligible). Current status: Approved.

Indication

Newly diagnosed multiple myeloma (transplant eligible)

Regulatory details

  • Company: Johnson & Johnson
  • Therapeutic area: Oncology
  • Application type: sBLA
  • Review type: Priority
  • PDUFA date: 2026-01-27
  • Outcome: Approved
Darzalex Faspro (D-VRd) PDUFA Date — Johnson & Johnson