Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats previously treated, unresectable locally advanced or metastatic cholangiocarcinoma…. Sold as Pemazyre. Every FDA application for this active ingredient: 1 branded and 1 generic.
As of Nov 15, 2026, FDA lists 2 applications for Pemigatinib (sold as Pemazyre), first approved Apr 17, 2020, with 1 new use approved and 0 published complete response letters.
First approved: Apr 17, 2020
Applications: 2
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $31.2M
Orphan exclusivity until: Aug 26, 2029
First approved in the EU: Mar 26, 2021
First approved in Japan: Mar 23, 2021
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 11 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
PemazyreA drug with a new indication and a new dosage for the treatment of FGFR1 fusion gene-positive myeloid/lymphoid neoplasms. · Incyte Biosciences Japan G.K. · Mar 27, 2023
Pemazyre, new ingredientA drug with a new active ingredient indicated for the treatment of unresectable FGFR2 fusion gene-positive biliary tract cancer that has progressed after… · Incyte Biosciences Japan GK · Mar 23, 2021
Clinical Trials
18 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
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
