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The US food and drug Administration (FDA) has granted orphan drug status SD-809 (deutetrabenazine) for the treatment of chorea associated with Huntington disease (HD). The compound is being developed by an Israeli drug manufacturer, Teva Pharmaceutical Industries (NY...

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EMA grants BioMarin’s Brinuera orphan drug status for CLN2 disease

Release Date: 05 December 2016

BioMarin pharmaceuticals Inc. declares its leading drug candidate, Brinuera as orphan drug as approved by European Medicinal Agency (EMA) for the treatment of a form of Batten disease, CLN2 disease usually found in children. The disease ...

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FDA grants orphan drug status to Singh Biotechnology

Release Date: 04 December 2016

Singh Biotechnology, a pharmaceutical company, announces that its SBT-100, its novel anti-STAT3 (Signal Transducer and Activator of Transcription 3) B VHH13 single domain antibody (sdAb) SBT-100, has been granted as orphan drug designati...

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Ra’s RX101494 receives orphan drug designation for PNH by EU

Release Date: 04 December 2016

Ra pharmaceuticals announce that European Union has granted orphan drug designation to its leading candidate, RA101495 for the treatment of Paroxysmal Nocturnal Hemoglobinuria. 

 

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GX-H9 receives orphan designation for growth hormone deficiency

Release Date: 03 December 2016

The Food and Drug Association has granted orphan drug designation to Generix’s leading product, GX-H9, for the treatment of patients with growth hormone deficiency.

 

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European Union grants orphan drug status to Crenolanib

Release Date: 03 December 2016

Arog Pharmaceuticals declared that its leading drug candidate has received orphan drug designation for the treatment of patients with acute myeloid leukemia and soft tissue sarcoma.

 

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ELX-02 receives orphan drug status for MPS I

Release Date: 02 December 2016

Eloxx pharmaceuticals announces that its leading drug candidate has been approved as an orphan drug for the treatment of patients with novel mucopolysaccharidosis Tx type 1 (MPS I) by the US Food and Drug Administration (FDA). ELX-02 is ...

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EU grants orphan drug status to Respiratorius’s VAL001

Release Date: 02 December 2016

The European Commission has granted orphan drug status to VAL001, the leading product candate from respiratorius pharmaceuticals for the treatment of diffused large b-cell lymphoma.

 

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Cytori’s ECCS- 50 granted as orphan drug status for scleroderma

Release Date: 02 December 2016

Cytori pharmaceuticals declared that its leading product ECCS 50 has been granted orphan drug status by Food and Drug Administration (FDA) for the treatment of patients with scleroderma. 

 

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Resunab by Corbus Pharma receives Orphan drug status by EC

Release Date: 01 December 2016

Corbus Pharmaceutical Holdings Inc. announces that its leading asset has been granted orphan drug designation by European Commission for the treatment of patients with Cystic Fibrosis. Resunab is the synthetic oral endocannabinoid-mimeti...

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SGT-001 declared orphan drug for DMD

Release Date: 30 November 2016

Solid Biosciences and Solid GT announces that US Food and Drug Administration (FDA) have granted Orphan drug status to SGT001 for the treatment of Duchenne Muscular Dystrophy (DMD). It is a rare and progressive muscle wasting disease tha...

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Iomab-B receives EMA orphan drug status for AML

Release Date: 30 November 2016

Iomab-B manufactured by Actinium Pharmaceuticals Inc. has been declared as orphan drug by European Medicines Agency for the treatment of patients with Acute Myeloid Leukemia (AML). The drug has the clinical tested usage in the treatment ...

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DPX-Survivac receives orphan drug status from EMA

Release Date: 30 November 2016

The US Food and Drug Association (FDA) have granted orphan drug designation Immunovaccine’s leading asset, DPX- Survivac for the treatment of patients with ovarian cancer. The EMA grants orphan designation to rare diseases that are defined as life-threatening o...

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Eloxx pharmaceuticals receives orphan drug designation for ELX-02 in Mucopolysacchardisis Type 1 (MPS 1) in US

Release Date: 29 November 2016

Eloxx Pharmaceuticals, a biotechnology firm focusing on developing and commercializing medicines and treatments for rare diseases, announces that Food and Drug Administration in US and European Medicine Agency (EMA) has granted orphan dr...

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Lundbeck’s carnexiv receives FDA orphan drug status

Release Date: 29 November 2016

Lundbeck declares orphan drug designation by Food and Drug Association (FDA) for its leading product, Carnexiv injection for the treatment of oral carbamazepine formulations in adults with certain types of seizures when oral administrati...

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