🇺🇸 LOARGYS in United States

FDA authorised LOARGYS on 23 February 2026

Marketing authorisation

FDA — authorised 23 February 2026

  • Application: BLA761211
  • Marketing authorisation holder: IMMEDICA PHARMA AB
  • Local brand name: LOARGYS
  • Indication: Injectable — Injection
  • Status: approved

The FDA approved LOARGYS, a new molecular entity, on 23 February 2026. The marketing authorisation was granted to IMMEDICA PHARMA AB under the standard expedited pathway. The approval was based on a new molecular entity application (BLA761211).

Read official source →

LOARGYS in other countries

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

Other Other approved in United States

Frequently asked questions

Is LOARGYS approved in United States?

Yes. FDA authorised it on 23 February 2026.

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

IMMEDICA PHARMA AB holds the US marketing authorisation.