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February 25, 2013
18:02 EDTMNOVFDA grants fast track designation for MedicNova's MN-166
MediciNova and the Jasdaq Market of the Osaka Securities Exchange (Code Number: 4875), announced that it has received Fast Track designation from the U.S. FDA for MN-166 (ibudilast) for the treatment of methamphetamine dependence. Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended to treat serious diseases and have the potential to fill an unmet medical need. An important feature of the FDA's Fast Track program is that it emphasizes early and frequent communication between the FDA and the sponsor throughout the entire drug development and review process to improve the efficiency of product development. Accordingly, Fast Track status can potentially lead to a shortened timeline to ultimate drug approval.
News For MNOV From The Last 14 Days
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October 23, 2014
19:04 EDTMNOVMediciNova says CDC supports recruitment for clinical trial of MN-166
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October 22, 2014
19:01 EDTMNOVMediciNova confirmsFDA granted orphan drug designation to MN-001
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07:28 EDTMNOVNortheast Amyotrophic Lateral Sclerosis Consortium to hold annual meeting
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October 21, 2014
18:05 EDTMNOVMediciNova granted orphan status for idiopathic pulmonary fibrosis drug
The FDA posted on its website that MediciNova has been granted orphan status for its treatment of idiopathic pulmonary fibrosis. Reference Link

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