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Concert Pharmaceutical Inc. announced that US Food and Drug Administration have granted orphan drug designation to company’s novel drug, CTP-656 for the treatment of Cystic Fibrosis. The novel drug candidate is the company’s ...

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FDA grants orphan drug designation to TG Therapeutics to treat Diffuse Large B-cell Lymphoma

Release Date: 02 February 2017

US Food and Drug Administration (FDA) has granted orphan drug designation to covering the combination of TG-1101 (ublituximab), the TG Therapeutics' s novel, glycol-engineered anti-CD20 monoclonal antibody, and TGR-1202 the Company&rsquo...

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Benitec’s BB-301 receives Orphan drug status to treat OMPD

Release Date: 01 February 2017

Benitec Biopharma Limited, a pharmaceutical firm announced that European Commission has granted orphan drug designation to the firm’s leading drug candidate for the treatment of patients with oculopharyngeal muscular dystrophy (OPM...

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Nintedanib receives orphan drug award for mesothelioma

Release Date: 31 January 2017

The US Food and Drug Administration (FDA) have awarded orphan drug designation to Nintedanib for the treatment of patients with asbestos-related cancer mesothelioma.

 

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Orphan status for Manchester Biotech’s antifungal in EU

Release Date: 30 January 2017

Manchester, a UK based pharmaceutical company has announced that its leading clinical candidate the antifungal F901318, has been awarded with orphan designation by European Medicines Agency (EMA). The antifungal F901318 is the first memb...

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FDA grants orphan status to Marinus Pharma

Release Date: 28 January 2017

US Food and Drug Administration has granted orphan drug status to Marinus Pharma’s ganaxolone – a CNS-selective GABAA modulator – for the treatment of Fragile X Syndrome, a genetic condition that causes intellectual dis...

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Hansa Medical receives orphan drug status for Ides in Europe

Release Date: 27 January 2017

Handa Medical, a pharmaceutical company announced that European medicines Agency has granted orphan drug designation to its leading product candidate, recombinant IdeS for the prevention of graft rejection following solid organ transplan...

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European orphan drug award for Agilis Bio therapeutics for AADC Deficiency

Release Date: 25 January 2017

Agilis Bio therapeutics Inc., a biotechnology company focused to develop DNA therapeutics for rare genetic diseases that affect the central nervous system (CNS) has recently declared that European Commission has granted Orphan Medicinal ...

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MeiraGTx receives Orphan Drug Designation for A004 Gene Therapy for Retinitis Pigmentosa

Release Date: 24 January 2017

The US Food and Drug Administration (FDA) has granted orphan drug status to MeiraGTx’ s novel therapy treatment, A004 Gene therapy for the treatment of X-linked retinitis pigmentosa (XLRP). A004 is the proprietary AAV-mediated gene...

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EU Commission grants orphan drug designation to Nefecon® For Treatment Of Iga Nephropathy

Release Date: 23 January 2017

Pharmalink AB, a focused pharmaceutical company has announced that its leading drug therapy Nefecon (budesonide) has received orphan drug designation for the treatment of Iga Nephropathy, an inflammatory kidney disease, by European Commi...

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FDA grants orphan designation for ABTL0812 in Pancreatic Cancer

Release Date: 21 January 2017

US Food and Drug Administration (FDA) has awarded ABTL0812, a leading candidate of Ability Pharmaceuticals, with orphan drug designation for the treatment of patients with pancreatic cancer. Previously the drug has been designated as orp...

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Escend’s ES3000 receives FDA orphan Drug status for AML

Release Date: 20 January 2017

Office of Orphan Products Development (OOPD) of US Food and Drug Administration (FDA) has granted orphan drug designation to ES3000, a leading product candidate of Escend’s Pharmaceuticals, a privately owned firm dedicated to devel...

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FDA orphan drug status for Cellspan Esophageal Implant by Biostage

Release Date: 19 January 2017

Biostage Inc., a biotechnology company focused on producing bioengineered organ implants to treat cancers and other life-threatening conditions of the esophagus, bronchus and trachea declared that US Food and Drug Administration has gran...

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Eiger Bio's exendin 9-39 receives orphan drug status for hyperinsulinemic hypoglycemia

Release Date: 18 January 2017

The US food and Drug Administration has designated Eiger BioPharmaceuticals' (EIGR -1.2%) exendin 9-39 as an Orphan Drug for the treatment of hyperinsulinemic hypoglycemia, a range of disorders characterized by excessive levels of insuli...

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FDA grants orphan drug status to Profounda Inc. to treat PAM

Release Date: 17 January 2017

Profounda, Inc. ("Profounda") announced that it has received the US Food and Drug Administration's (FDA) Orphan Drug Designation for the treatment of Primary Amebic Meningoencephalitis (PAM) with miltefosine.  Profounda licensed mil...

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