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US Food and Drug Administrations has granted orphan drug designation to Tasquinimod, investigational novel agent developed by Active Biotech, a leading biopharmaceutical company for the effective treatment for patients with multiple myel...

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FDA orphan drug status given to Exelixis, Inc. (EXEL) for the Treatment of Hepatocellular Carcinoma

Release Date: 15 April 2017

US Food and Drug Administration have granted orphan drug designation to Exelixis’ novel product cabozantinib for the treatment of hepatocellular carcinoma (HCC). A pivotal phase 3 trial (CELESTIAL) of cabozantinib is in process wit...

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Annamycin from Moleculin receives orphan drug status for the Treatment of Acute Myeloid Leukemia

Release Date: 15 April 2017

Moleculin Biotech, Inc, a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Canc...

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FDA grants orphan drug designation to SB-913 Genome Editing Treatment for MPS II

Release Date: 15 April 2017

Sangamo Therapeutics, Inc., a leading pharmaceutical company dedicated to develop gene therapies and therapeutic genome editing has recived orphan drug designation from US Food and Drug Administration for company’s genome editing p...

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DLBCL receives FDA orphan drug designation for eFT508

Release Date: 15 April 2017

US Food and Drug Administration has announced orphan drug designation to eFT508, a highly selective inhibitor of MNK1 and MNK2 for the treatment of diffuse large B-cell lymphoma. The drug is developed by eFFECTOR Therapeutics. The compan...

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AstraZeneca NMOSD Drug receives orphan drug designation

Release Date: 15 April 2017

European Medicine Agency has Announced orphan drug designation for inebilizumab (earlier known as MEDI-551) developed by AstraZeneca PLC (AZN) for the treatment of neuromyelitis optica spectrum disorder (NMOSD).  The drug has alread...

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FDA grants orphan drug status to Sapience Therapeutics (ST-36)

Release Date: 14 April 2017

Sapience Therapeutics, a leading biotechnonology company dedicated to develop therapies for complicated cancer cases, declared that US Food and Drug Administration (FDA) has awarded company’s novel product protein-based therapeutic...

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FDA orphan status for VAL001

Release Date: 14 April 2017

Respitorius, a leading pharmaceutical firm has announced that US Food and Drug Administration has granted orphan drug status for VAL001 (valproic acid) for the treatment of diffuse large b-cell lymphoma. The drug is presently undergoing ...

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Opko receives orphan drug designation for CUR-1916 in Dravet Syndrome

Release Date: 14 April 2017

Opko Health Inc., a leading pharmaceutical company has announced that US Food and Drug Administration has granted orphan drug designation for company’s oligonucleotide-based AntagoNAT (CUR-1916) for the treatment of Dravet Syndrome...

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European Union grants orphan drug designation to LSK BioPharma Apatinib

Release Date: 13 April 2017

LSK BioPharma, a leading biopharmaceutical company announced that company’s novel small-molecule angiogenesis inhibitor, Apatinib is awarded with orphan drug designation from European Commission for the effective treatment of gastr...

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EMA grants orphan drug designation to aTyr Pharma for the Treatment of Limb Girdle Muscular Dystrophy with Resolaris

Release Date: 12 April 2017

European Medicine Agency has granted orphan drug designation to aTyr Pharma, Inc. (LIFE), a biotherapeutics company engaged in the discovery and development of Physiocrine-based therapeutics to address severe, rare diseases, for company&...

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FDA grants orphan drug designation to Miragen Therapeutics

Release Date: 12 April 2017

Miragen Therapeutics, a leading biopharmaceutical company has announced that US Food and Drug Administration have granted orphan drug designation to its novel product, MRG-106 for the treatment of mycosis fungoides.

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Prometic PBI-4050 receives FDA orphan drug status for Alström Syndrome

Release Date: 12 April 2017

US Food and Drug Administration has announced orphan drug designation to orally active, anti-fibrotic, lead drug candidate, PBI-4050 Drug, for the treatment of Alstrӧm Syndrome (AS).  The disease is chronically debilitating as it c...

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FDA announces orphan drug status for aNK Natural Killer Cell Therapy in Merkel Cell Carcinoma

Release Date: 11 April 2017

NantKwest, Inc. has recently received orphan drug designation from US Food and Drug Administration (FDA) for its leading drug candidate, activated natural killer (aNK) cell therapy for treatment of patients with advanced Merkel cell carc...

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FDA grants orphan drug designation to EnGeneIC for Targeted EDV™ Nanocells to Treat Glioblastoma Multiforme

Release Date: 10 April 2017

US Food and Drug Administration has announced orphan drug status for EGFR-targeted, doxorubicin-loaded EDV Nano cells for the treatment of glioblastoma multiforme (GBM) the most aggressive form of brain cancer, developed by EnGeneIC Ltd....

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