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.