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XNK Therapeutics receives US orphan drug status for NK cell-based immunotherapy in multiple myeloma
pharmaceutical-business-review
November 09, 2020
XNK Therapeutics announced it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its leading investigational drug candidate in the treatment of multiple myeloma (MM).
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Apoptosis-Targeting Drug Candidates Granted Two More Orphan Drug Designations
americanpharmaceuticalreview
October 16, 2020
Ascentage Pharma announced the US Food and Drug Administration (FDA) has granted two Orphan Drug Designations (ODDs) to two of the company's apoptosis-targeting assets: the MDM2-p53 inhibitor, APG-115 ...
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FDA grants Orphan Drug Designation to two cancer treatments
europeanpharmaceuticalreview
October 10, 2020
The FDA has given small molecules APG-115 and APG-1252, two cancer treatments, Orphan Drug Designation.
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Neurophth Therapeutics' Treatment of Leber's Hereditary Optic Neuropathy Gene Therapy NR082 was Granted Orphan Drug Designation by U.S. FDA
prnasia
September 27, 2020
Neurophth Therapeutics, Inc., today announced that its leading candidate, NR082 (rAAV2-ND4, NFS-01 project), was granted an orphan drug designation (ODD) by the U.S. FDA for the treatment of Leber's Hereditary Optic Neuropathy associated with ND4 mutation
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Ascentage Pharma’s Bcl-2 inhibitor APG-2575 granted orphan drug Designation by FDA to treat chronic lymphocytic leukaemia
pharmaceutical-business-review
September 23, 2020
Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the US Food and Drug Administration (FDA) ...
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Chemomab Receives EU Orphan Drug Designation for Primary Sclerosing Cholangitis Treatment
americanpharmaceuticalreview
August 27, 2020
Chemomab announces the European Commission (EC) has granted Orphan Drug Designation (ODD) to its lead drug candidate CM-101 for the treatment of patients with Primary Sclerosing Cholangitis (PSC) ...
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Selumetinib Granted Orphan Drug Designation in Japan for Neurofibromatosis Type 1
americanpharmaceuticalreview
July 09, 2020
AstraZeneca announced selumetinib has been granted orphan drug designation (ODD) in Japan for the treatment of neurofibromatosis type 1 (NF1), a rare and debilitating genetic disease.
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US FDA Grants Orphan Drug Designation (ODD) for Prestige BioPharma’s PBP1510 Anti-PAUF Monoclonal Antibody for the Treatment of Pancreatic Cancer
B3C newswire
July 01, 2020
Prestige BioPharma Ltd. (hereinafter “Prestige BioPharma”) today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its first-in-class anti-PAUF monoclonal antibody, PBP1510, for the treatment of pancreat
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CNS Announces Filing of Orphan Drug Designation for Brain Cancer Drug
americanpharmaceuticalreview
April 26, 2020
CNS Pharmaceuticals has filed an application with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for its lead product Berubicin.
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FDA grants Orphan Drug Designation to phenylketonuria treatment
europeanpharmaceuticalreview
April 08, 2020
A new treatment called APR-OD031 has been given Orphan Drug Designation (ODD) by the FDA, for the treatment of phenylketonuria.