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FDA Grants Orphan Drug Designation to Lurbinectedin
americanpharmaceuticalreview
August 06, 2018
PharmaMar announces that lurbinectedin has been granted orphan drug status by the FDA for the treatment of small cell lung cancer。
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FDA grants orphan drug designation to elamipretide for LHON
europeanpharmaceuticalreview
May 02, 2018
The FDA granted Orphan Drug Designation to elamipretide, for the treatment of Leber’s hereditary optic neuropathy…
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KL1333 receives FDA ODD for mitochondrial diseases
europeanpharmaceuticalreview
April 24, 2018
NeuroVive Pharmaceutical AB has been granted Orphan Drug Designation for its project KL1333 for treatment of inherited mitochondrial respiratory chain diseases…
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Alnylam Receives Positive Opinion for Orphan Drug Designation in the EU for ALN-TTRsc02
americanpharmaceuticalreview
April 24, 2018
Alnylam Pharmaceuticals announced the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion
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NeuroVive's KL1333 Receives FDA Orphan Drug Designation for Treatment of Mitochondrial Diseases
biospace
April 19, 2018
NeuroVive Pharmaceutical AB today announced that it has been granted Orphan Drug Designation by the United States FDA Office of Orphan Products Development for its project KL1333 for treatment of inherited mitochondrial respiratory chain diseases (MRCD)
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Stealth BioTherapeutics Granted Orphan Drug Designation for Elamipretide for Treatment of Barth Syndrome
biospace
April 10, 2018
Stealth today announced that the FDA Office of Orphan Products Development has granted Orphan Drug Designation to Stealth's investigational drug candidate, elamipretide, for the treatment of patients with Barth syndrome.
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FDA Grants Orphan Drug Designation for BPN14770
americanpharmaceuticalreview
April 09, 2018
Tetra Discovery Partners announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for BPN14770 for the treatment of Fragile X Syndrome
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Martin Pharmaceuticals Receives FDA Orphan Drug Designation for LIVANTRA™
biospace
March 30, 2018
Martin Pharmaceuticals, has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for LIVANTRA™ in the treatment of Acute on Chronic Liver Failure.
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Latest Trends in Orphan Drug Pricing and Reimbursement, 2018 Report
biospace
March 29, 2018
The "Latest Trends in Orphan Drug Pricing and Reimbursement" report has been added to ResearchAndMarkets.com's offering.
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Soligenix Receives Orphan Drug Designation from the European Commission for RiVax® for Prevention of Ricin Poisoning
biospace
March 23, 2018
RiVax® has previously been granted orphan drug designation from the US Food and Drug Administration (FDA).