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The approval was based on its bioequivalence to the standard melphalan formulation (Alkeran) in a phase 2 clinical study. Evomela has been granted Orphan Drug Designation by the

The treatment is for patients with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or after platinum-based chemotherapy in the metastatic setting, or whose

The trial is a double-blind, placebo-controlled, three arm, multicenter study enrolling approximately 350 patients with Lactose Intolerance symptoms. Patients will undergo a 30-day treatment process, followed by a

The Prescription Drug User Fee Act (PDUFA) action date for completion of FDA review of the eteplirsen is May 26, 2016. The FDA has granted eteplirsen Priority Review

This is the second orphan drug designation obtained by ProNAi for PNT2258 for the treatment of DLBCL, following a similar grant by the European Commission in August 2015.

Aeglea plans to start a phase 1 dose escalation study in the first half of this year in patients with relapsed and refractory acute myeloid leukemia (AML) and

In the phase 3 study of 309 patients with secondary, or high risk, acute myeloid leukemia, those who received Vyxeos on average lived for 9.56 months after the

The 120-patient trial demonstrated that patients taking Epidiolex achieved a median reduction in monthly convulsive seizures of 39%, compared with a 13% reduction for those on a placebo,

The collaboration will further explore the scientific and clinical role of citrullinated proteins in the treatment of cancer. Scancell’s Moditope platform technology overcomes the immune suppression induced by