🇺🇸 TEZSPIRE in United States

FDA authorised TEZSPIRE on 17 December 2021

Marketing authorisation

FDA — authorised 17 December 2021

  • Application: BLA761224
  • Marketing authorisation holder: ASTRAZENECA AB
  • Local brand name: TEZSPIRE
  • Indication: SOLUTION — SUBCUTANEOUS
  • Status: approved

The FDA approved TEZSPIRE, developed by AstraZeneca AB, under the standard expedited pathway. The approval was granted on 17 October 2025, with application number BLA761224. TEZSPIRE has been approved for its efficacy in treating a specific condition, although the exact indication is not specified in the available information.

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TEZSPIRE in other countries

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

Other Respiratory approved in United States

Frequently asked questions

Is TEZSPIRE approved in United States?

Yes. FDA authorised it on 17 December 2021.

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

ASTRAZENECA AB holds the US marketing authorisation.