🇺🇸 Unloxcyt in United States

FDA authorised Unloxcyt on 13 December 2024

Marketing authorisations

FDA — authorised 13 December 2024

  • Application: BLA761297
  • Marketing authorisation holder: CHECKPOINT THERAPEUTICS INC
  • Local brand name: UNLOXCYT
  • Indication: INJECTABLE — INJECTION
  • Status: approved

The FDA approved Unloxcyt, developed by Checkpoint Therapeutics Inc, for its approved indication on 21 November 2025. The application number for this approval is BLA761297. Unloxcyt was granted marketing authorisation through the standard expedited pathway.

Read official source →

FDA

  • Marketing authorisation holder: CHECKPOINT THERAPEUTICS INC
  • Status: approved

Unloxcyt in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in United States

Frequently asked questions

Is Unloxcyt approved in United States?

Yes. FDA authorised it on 13 December 2024; FDA has authorised it.

Who is the marketing authorisation holder for Unloxcyt in United States?

CHECKPOINT THERAPEUTICS INC holds the US marketing authorisation.