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FDA announces a strategic plan to eliminate orphan designation backlog biospectrumasia
July 05, 2017
The agency intends to communicate around the successful elimination of the backlog by mid-September.
Tazemetostat Granted Orphan Drug Designation for the Treatment of Soft Tissue Sarcoma americanpharmaceuticalreview
June 22, 2017
Epizyme announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to tazemetostat, the company’s first-in-class EZH2 inhibitor, for the treatment of patients with soft tissue sarcoma (STS).
Cytokinetics receives FDA orphan drug status for Ck-2127107 to treat SMA pharmaceutical-technology
May 18, 2017
Biopharmaceutical company Cytokinetics’ CK-2127107has received orphan drug designation from the Office of Orphan Products Development of the US Food and Drug Administration (FDA) for the potential treatment of spinal muscular atrophy (SMA).
Xencor's XmAb5871 Receives Orphan Drug Designation from FDA for Treatment of IgG4-Related Disease americanpharmaceuticalreview
May 12, 2017
Xencor announced XmAb5871 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of IgG4-Related Disease (IgG4-RD)...
AlzProtect : The American Food and Drug Administration (FDA) Has Granted AZP2006 the Orphan Drug Des contractpharma
May 05, 2017
The drug candidate AZP2006 has an original mechanism of action and aims to treat several neurodegenerative pathologies for which there is no treatment: Tauopathies including Alzheimer's disease and Progressive Supranuclear Palsy (PSP).
RedHill Biopharma Receives FDA Orphan Drug Designation for YELIVA® for the Treatment of Cholangiocar b3cnewswire
April 05, 2017
Orphan Drug designation allows RedHill to benefit from various development incentives to develop YELIVA® (ABC294640) for cholangiocarcinoma, as well as a seven-year marketing exclusivity period for the indication, if approved for marketing
OPKO Receives FDA Orphan Drug Status for its New Oligonucleotide to Treat Genetic Neurological Disor firstwordpharma
March 23, 2017
OPKO Pharmaceuticals LLC announces that the Company has received orphan drug designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development for...
Moleculin Receives Orphan Drug Designation for Annamycin for the Treatment of Acute Myeloid Leukemia firstwordpharma
March 23, 2017
Moleculin Biotech, Inc. announced its lead candidate, Annamycin (also known as "Liposomal Annamycin"), an anthracycline, has received Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML).
Boehringer's investigational anti-CD33 monoclonal antibody gains orphan drug designation for treatme cphi-online
March 15, 2017
BI 836858 was previously granted orphan drug designation for the treatment of patients with AML.
FDA Grants Orphan Drug Designation to CSRA’s DynPort Vaccine Company for Plague Vaccine firstwordpharma
March 09, 2017
DynPort's clinical stage recombinant Yersinia pestis rF1V plague vaccine to benefit from FDA Orphan Drug Designation

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