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Merck KGaA, Darmstadt, Germany Announces Orphan Drug Designation for M7824
americanpharmaceuticalreview
December 12, 2018
Merck KGaA, Darmstadt, Germany announced the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to M7824, the first regulatory designation.....
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FDA Grants Orphan-drug Designation for LMTX in Frontotemporal Dementia
americanpharmaceuticalreview
December 11, 2018
TauRx announced the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to LMTX for the "treatment of frontotemporal dementia.” The term Frontotemporal Dementia (FTD) covers.....
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US FDA grants ODD for OBI Pharma’s OBI-888 to treat pancreatic cancer
pharmaceutical-technology
November 29, 2018
Taiwan, Chinaese biopharma company OBI Pharma has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for OBI-888 to treat pancreatic cancer patients......
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FDA grants ODD for AstraZeneca’s Fasenra to treat EGPA
pharmaceutical-technology
November 29, 2018
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for AstraZeneca’s Fasenra (benralizumab) to treat eosinophilic granulomatosis with polyangiitis (EGPA).....
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OBI Pharma Granted FDA Orphan Drug Designation for OBI-888 for the Treatment of Pancreatic Cancer
pharmafocusasia
November 26, 2018
OBI Pharma, Inc., a Taiwan, China biopharma company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for....
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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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FDA grants two orphan drug designations for HCC
europeanpharmaceuticalreview
August 21, 2017
The FDA has granted two orphan drug designations for T cell therapy products for the treatment of hepatocellular carcinoma…