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UK biotech firm F2G has announced that European Medicines Agency has grnated orphan drug status to its lead clinical candidate, F901318, for the treatment of invasive Aspergillosis and rare mould infections caused by Scedosporium species...

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US FDA grants orphan drug status to MacroGenics’ MGD006

Release Date: 15 January 2017

MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infecti...

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Yisheng Biopharma's PIKA Rabies Vaccine receives orphan drug status from FDA

Release Date: 14 January 2017

US Food and Drug Administration has granted orphan drug designation for Yisheng’s lead vaccine candidate, PIKA rabies vaccine, which is an innovative rabies vaccine independently developed by Yisheng Biopharma Co., Ltd. ("Yisheng B...

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FDA orphan drug status to Acucela for Stargardt Disease

Release Date: 13 January 2017

Acucela Inc. specializes in identifying and developing novel therapeutics to treat and slow the progression of sight-threatening ophthalmic diseases, declared that US Food and Drug Administration has granted orphan drug designation to it...

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Senhwa Biosciences CX-4945 receives orphan drug status in Cholangiocarcinoma

Release Date: 13 January 2017

Senhwa Biosciences Inc. recently declared that US Food and Drug Administration has granted it novel product CX-4945 orphan drug designation for the treatment of patients with Cholangiocarcinoma.

 

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Alxion Pharma receives FDA orphan drug designation for PNH

Release Date: 12 January 2017

Alexion Pharmaceuticals Inc. has recently announced that US Food and Drug Administration has granted orphan drug status to leading candidate ALXN 1210 for the treatment of patients suffering from paroxysmal nocturnal hemoglobinuria (PNH)...

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FDA grants orphan drug status to Sangamo’s SB-318 Genome editing treatment for MPS-I

Release Date: 12 January 2017

Sangamo Therapeutics, one of the leaders in therapeutics genome editing announced that Food and Drug Administration in US has granted orphan drug designation to its novel treatment SB-318, a genome editing product candidate for the treat...

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FDA grants orphan drug designation to PTCT’s RG-7916

Release Date: 11 January 2017

US Food and Drug Administration has announced orphan drug status for PTC therapeutics’ leading candidate RG-7916 for the treatment of patients with Spinal Muscular Atrophy (SMA). RG7916 is part of PTC's joint development program in...

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EMA grants orphan drug designation to AB-201 for juvenile batten disease

Release Date: 10 January 2017

Abeona Therapeutics, a biopharmaceutical company announced that European Medicines Agency (EMA) has granted orphan drug designation to the company’s novel candidate AB-201 to treat patients with Juvenile Batten Disease, a fatal lys...

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TG-1101 and TG-1202 Combo receives orphan drug designation: FDA

Release Date: 10 January 2017

TG Therapeutics, a biopharmaceutical company focused on developing medication and therapies for the treatment of rare and deadly diseases has announced that Food and Drug Administration in US has granted orphan drug status to the combina...

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FDA grants orphan drug status to Marinus’ Ganaxolone

Release Date: 09 January 2017

Marinus Pharmaceuticals Inc, a pharmaceutical company focused to develop innovative therapies to epilepsy and neuropsychiatric disorders declared orphan drug designation for its leading product candidate Ganaxolone for the treatment of F...

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Cellceutix announces orphan drug status for Kevetrin

Release Date: 08 January 2017

Cellceutix Corp (OTCMKTS:CTIX) is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antimicrobial applications. Cellceutix believes it has a world-class portfolio of compounds and is ...

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Neurotrope receives orphan drug designation for bryostatin-1 by FDA

Release Date: 07 January 2017

The FDA has granted Orphan Drug Designation to Neurotrope for bryostatin-1 as a treatment for Fragile X Syndrome. Bryostatin-1 has undergone testing in over 1,500 people establishing a large safety database. Neurotrope is conducting a Ph...

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FDA grants orphan drug designation for Biogen’s Spinraza Spinal Muscular Atrophy

Release Date: 06 January 2017

US Food and Drug Administration has recently announced that orphan drug designation for Spinraza (nusinersen), making Biogen drug to be first available to treat patients with Spinal muscular Atrophy (SMA) in adults and children. The drug...

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FDA grants orphan drug status to CymaBay’s MBX-8025

Release Date: 05 January 2017

US Food and Drug Administration (FDA) has granted orphan drug designation to MBX-8025, a leading drug candidate of CymaBay Therapeutics for the treatment of primary biliary cholangitis (PBC).

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