🇺🇸 PEGZILARGINASE in United States

FDA authorised PEGZILARGINASE on 23 February 2026

Marketing authorisation

FDA — authorised 23 February 2026

  • Application: BLA761211
  • Marketing authorisation holder: IMMEDICA PHARMA AB
  • Indication: Type 1 - New Molecular Entity
  • Status: approved

The FDA approved PEGZILARGINASE, a new molecular entity, for marketing in the United States on 23 February 2026. The application number is BLA761211. IMMEDICA PHARMA AB is the marketing authorisation holder. PEGZILARGINASE was approved through the standard expedited pathway.

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PEGZILARGINASE in other countries

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

Frequently asked questions

Is PEGZILARGINASE approved in United States?

Yes. FDA authorised it on 23 February 2026.

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

IMMEDICA PHARMA AB holds the US marketing authorisation.