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Sold as Rhapsido. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Remibrutinib (sold as Rhapsido), first approved Sep 30, 2025, with 1 new use approved and 0 published complete response letters.
First approved: Sep 30, 2025
Applications: 1
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $2.2M
First approved in the EU: Apr 23, 2026
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Product
Part
Spending, 2025
Change
Beneficiaries
Rhapsido
Part D
$2.2M
New
291
What Pharmacies Pay
Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change
RHAPSIDO 25 MG TABLET: $72.50 per unitBrand · new this year
Approvals in the EU (EMA)
First approved in the EU 7 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Novartis