🇺🇸 Scemblix in United States

FDA authorised Scemblix on 2 October 2025

Marketing authorisation

FDA — authorised 2 October 2025

  • Application: NDA215358
  • Marketing authorisation holder: NOVARTIS
  • Indication: Efficacy
  • Status: approved

The US FDA approved Scemblix, a drug developed by Novartis, for its approved indication on 2 October 2025. The application number for this approval is NDA215358. Scemblix was granted marketing authorisation through the standard expedited pathway.

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Scemblix 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 Scemblix approved in United States?

Yes. FDA authorised it on 2 October 2025.

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

NOVARTIS holds the US marketing authorisation.