FDA — authorised 28 January 2022
- Marketing authorisation holder: GENENTECH INC
- Status: approved
🇺🇸 Vabysmo in United States
FDA authorised Vabysmo on 28 January 2022
Marketing authorisations
FDA — authorised 9 April 2026
- Application: BLA761235
- Marketing authorisation holder: GENENTECH INC
- Indication: Efficacy
- Status: approved
The FDA approved Vabysmo, a drug developed by Genentech Inc, for its approved indication on 9 April 2026. The application number for this approval is BLA761235. This approval was granted through the standard expedited pathway.
Vabysmo in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Vabysmo approved in United States?
Yes. FDA authorised it on 28 January 2022; FDA authorised it on 9 April 2026.
Who is the marketing authorisation holder for Vabysmo in United States?
GENENTECH INC holds the US marketing authorisation.