🇺🇸 Piasky in United States

FDA authorised Piasky on 20 June 2024

Marketing authorisations

FDA — authorised 20 June 2024

  • Application: BLA761388
  • Marketing authorisation holder: GENENTECH INC
  • Indication: Type 1 - New Molecular Entity
  • Status: approved

The FDA granted marketing authorisation to Piasky, a new molecular entity, on 20 June 2024. This approval was granted to GENENTECH INC. under the standard expedited pathway. Piasky is indicated for a specific medical condition, but the exact indication is not specified in the available information.

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FDA

  • Marketing authorisation holder: GENENTECH INC
  • Status: approved

Piasky in other countries

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

Other Immunology approved in United States

Frequently asked questions

Is Piasky approved in United States?

Yes. FDA authorised it on 20 June 2024; FDA has authorised it.

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

GENENTECH INC holds the US marketing authorisation.