🇺🇸 Anktiva in United States

FDA authorised Anktiva on 22 April 2024

Marketing authorisations

FDA — authorised 22 April 2024

  • Application: BLA761336
  • Marketing authorisation holder: ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SU
  • Indication: Type 1 - New Molecular Entity
  • Status: approved

The FDA approved Anktiva, a new molecular entity, for marketing in the United States on 22 April 2024. The approval was granted to Altro Bioscience, LLC, an indirect wholly-owned subsidiary. Anktiva was approved under the standard expedited pathway.

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FDA

  • Marketing authorisation holder: ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SU
  • Status: approved

Anktiva 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 Anktiva approved in United States?

Yes. FDA authorised it on 22 April 2024; FDA has authorised it.

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

ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SU holds the US marketing authorisation.