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Serodus announces orphan drug designation for its leading product, SER100 by US Food and Drug Administration (FDA) for the treatment of Pulmonary Arterial Hypertension (PAH). The company is planning for first clinical study in phase IIa ...

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EC grants orphan drug designation to Philogen SpA for the treatment of soft tissue sarcoma.

Release Date: 28 November 2016

Philogen SpA, a clinical stage biological company dedicated to develop and commercialize immunology and immune-oncology protein therapeutics, declared that European commission has granted orphan drug designation to L19TNF - a non-covalen...

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Invasive Aspergillus infections recieves orphan drug as SCY-078 by SCYNEXIS

Release Date: 27 November 2016

Scynexis, a pharmaceutical company specialized in drug development, declared its triterpenoid broad-spectrum antifungal agent, SCY-078 as orphan drug as approved by Food and Drug Administration for the treatment of invasive Aspergillus i...

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Solid Biosciences receives orphan drug designation from FDA and EMA for Duchenne Muscular Dystrophy

Release Date: 26 November 2016

Solid Bioscience and its subsidiaries declares that Food and Drug Administration and European Medicine Agency has granted orphan drug designation to company’s gene therapy candidate, SGT-001, for the treatment of patients with Duch...

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Theranexus’s THN102 receives orphan drug designation from FDA for treatment of Narcolepsy

Release Date: 25 November 2016

US Food and Drug Administration has granted orphan drug designation to THN102 developed by Theraneux, a clinical stage biopharmaceutical company, for the treatment of narcolepsy, a rare and highly debilitating sleep/wake disorder. The company has initiated a clinical...

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FDA grants orphan drug designation to Synlogic Proprietary Synthetic Biotic

Release Date: 24 November 2016

Synlogic, a privately owned bio-pharmaceutical company focusing on developing novel medicines by synthetic biology and microbiome platform, announces that US Food and Drugs Administration grants its investigational program involving a li...

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Yisheng Biopharma's Biological Product receives orphan drug status for Hepatocellular Carcinoma

Release Date: 23 November 2016

Yisheng Biopharma Co. Ltd. Is a bio pharmaceutical company specialized in development, research, manufacture, marketing and sales of immunotherapeutic products and vaccines, declared that US Food and Drugs Association has granted orphan drug designation to its leadin...

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Phyto-pain pharma declared the submission of orphan drug application for Delta-9-tetrahydrocannibinol and Cannabidiol

Release Date: 23 November 2016

PhytoPain Pharma Inc., a subsidiary of GrowPros Cannabis Ventures Inc. stated h submission of two applications for orphan drug designation for Delta-9-tetrahydrocannibinol and Cannabidiol to the US Food and Drugs Administration (FDA), or...

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True North’s TNT009 receives orphan drug status for Autoimmune Hemolytic Anemia, including Cold Agglutinin Disease (CAD)

Release Date: 22 November 2016

True north therapeutics, a clinical stage biotechnological company dedicated to develop several medication that complement to certain rare life threatening diseases, announces orphan drug designation approved by US Food and Drug Associat...

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FDA grants orphan drug designation to AAV1-FS344 for Inclusion Body Myositis

Release Date: 21 November 2016

US Food and Drug Association (FDA) announces orphan drug designation for Milo Biotechnology’s AAV1-FS344 for treatment of inclusion body myositis. AAV1-FS344 is a gene therapy delivered follistatin protein that increases muscle str...

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CD4CAR therapy receives FDA approval for orphan drug designation for peripheral T-cell Lymphoma

Release Date: 20 November 2016

FDA granted orphan drug designation to icell gene therapeutics for its chimeric antigen receptor-engineered T cells directed against the target protein CD4 to treat peripheral T-cell Lymphoma. These chimeric antigens are made up of patient’s own T-cells that a...

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EMA announces orphan drug designation for BP1001 for AML treatment

Release Date: 19 November 2016

Bio-Path Holding Inc. declares that European Medicine Agency has granted orphan drug Designation to BP1001 for treatment of acute myeloid leukemia (AML). BP1001 is introduced by Bio-Path Holding Inc. to fill the void of the treatments an...

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FDA announces orphan drug designation for Veliparib as NSCLC treatment

Release Date: 18 November 2016

US Food and drug Association (FDA) has declared Veliparib, an oral poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, developed by Abbvie (ABBV). Currently, Veliparib is undergoing investigation in combination with ch...

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FDA approves orphan drug status for Dusquetide for Macrophage Activation Syndrome

Release Date: 17 November 2016

Soligenix Inc., a pharmaceutical company, specialized in developing and commercializing medicines to treat rare diseases declared that Food and Drug association (FDA) has granted its leading candidate, Dusquetide, orphan drug designation...

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FDA announces orphan drug designation for DTX401 for the treatment of Glycogen Storage Disease Type Ia (GSDIa)

Release Date: 15 November 2016

Dimension Therapeutics Inc., a biopharmaceutical company specialized in developing gene therapies targeting liver related diseases, declared that US Food and Drug Association (FDA) granted orphan drug status for DTX401 for the treatment ...

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