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jelmyto

Generic: mitomycin·Code: UGN-101

jelmyto: developed by 1 company · 1 FDA decision.

jelmyto evidence translation

What we can confirm

What it means

Source-backed records connect jelmyto to URGN; that link alone does not prove the drug works.

What to watch

Watch for new trials or company disclosures after the FDA record.
BioSniper AIPage evidence connected

Prepared research question

How could jelmyto → URGN affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

low-grade upper tract urothelial cancer

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (1)
CompanyPhase
UroGen Pharma Ltd. (URGN)
low-grade upper tract urothelial cancer
Approved
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE JELMYTO ® is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). JELMYTO is an alkylating drug indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). ( 1 )(URGN)FDA ↗
NDA211728Type 5 - New Formulation or New ManufacturerOrphan DrugPriorityOtherPowder

Frequently asked questions

Who is developing jelmyto?

jelmyto is being developed by UroGen Pharma Ltd..

What is jelmyto's latest FDA decision?

The most recent tracked FDA decision for jelmyto is Approval for 1 INDICATIONS AND USAGE JELMYTO ® is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). JELMYTO is an alkylating drug indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). ( 1 ), dated April 15, 2020.