Rhapsido (remibrutinib)
New molecular entityPriority review
- Region
- 🇺🇸 US
- Active substance
- remibrutinib
- Company
- Novartis
- Status
- Approved
- FDA approval
- Tue 30 Sep 2025
- Designations
- New molecular entity, Priority review
- Application
- NDA218436
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Thu 23 Apr 2026🇪🇺 EU approval (EC decision)
Rhapsido (remibrutinib) approved in the EU
Marketing authorisation to Novartis Europharm Limited; Additional monitoring · source
Thu 26 Feb 2026🇪🇺 CHMP positive opinion
Rhapsido (remibrutinib): CHMP positive opinion
Novartis Europharm Limited; Additional monitoring · source
Same substance in other markets
- 🇪🇺 Rhapsido Authorised · Novartis Europharm Limited
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.