🇺🇸 Rytelo in United States

FDA authorised Rytelo on 6 June 2024

Marketing authorisations

FDA — authorised 6 June 2024

Application: NDA217779
Marketing authorisation holder: GERON
Local brand name: RYTELO
Indication: POWDER — INTRAVENOUS
Status: approved

The FDA approved Rytelo, a drug developed by GERON, on 14 April 2026. The approval was granted under the standard expedited pathway, with application number NDA217779. The approved indication for Rytelo is listed as 'Labeling', but further details on the specific condition or disease it treats are not provided.

Read official source →

FDA

Marketing authorisation holder: GERON
Status: approved

Rytelo in other countries

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

Other Oncology approved in United States

Frequently asked questions

Is Rytelo approved in United States?

Yes. FDA authorised it on 6 June 2024; FDA has authorised it.

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

GERON holds the US marketing authorisation.