Lantidra Chronology: 19 Years From IND Submission To Approval For The Cellular Therapy

Pink Sheet’s Drug Review Profile looks at the timeline behind the development and FDA review of CellTrans’ treatment for type 1 diabetes.

Drug Review Profile: Lantidra Chronology
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The development and US regulatory approval of CellTrans, Inc.’s Lantidra (donislecel-jujn), a cellular therapy for treating type 1 diabetes, was a long time in the making.

Almost 19 years passed between submission of the investigational new drug application in July 2004 and the product’s second-cycle approval...

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