CUTX-101 of Fortress Biotech gets US FDA rare pediatric disease designation to treat Menkes disease
Fortress Biotech, an innovative biopharmaceutical company focused on identifying, in-licensing and developing high-potential marketed and development-stage drugs and drug candidates, announced that... Read More
Recordati received exclusive rights to commercialize Juxtapid in Japan from Aegerion Pharmaceuticals
Posted on07 Feb 2019
TagsAegerion, HoFH, Juxtapid, Novelion Therapeutics, orphan drug, orphan drug designation, rare disease
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Recordati announces the signing of a license agreement with Aegerion Pharmaceuticals Inc., a subsidiary of Novelion Therapeutics Inc., for the exclusive rights... Read More
USFDA new drug approval: Xermelo for carcinoid syndrome diarrhea
Posted on03 Mar 2017
Tags2017 USFDA New Drug Apporval, Fast Track designation, orphan drug designation, priority review, Xermelo
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The U.S. Food and Drug Administration today approved Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for the treatment... Read More
ARMO BioSciences’ Immunotherapy AM0010 Receives Orphan Designation in Europe
Posted on24 Dec 2016
TagsEuropean Medicine Agency, Orphan Designation in Europe, orphan drug, orphan drug act, orphan drug designation
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ARMO BioSciences, Inc., a clinical-stage immuno-oncology company, announced that the European Commission (EC) has granted the Company’s lead investigational immuno-oncology drug AM0010... Read More
USFDA approved new drug Rubraca, rucaparib
The U.S. Food and Drug Administration today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian... Read More
FDA grants accelerated approval to Eteplirsen, first drug for Duchenne muscular dystrophy
Posted on23 Sep 2016
TagsDuchenne muscular dystrophy, Eteplirsen, Fast Track designation, orphan drug, orphan drug designation, priority review
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The U.S. Food and Drug Administration today approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular... Read More
Zymeworks’ ZW25, ZW33 received Orphan Drug designation for ovarian cancer
Zymeworks Inc., a biopharmaceutical company discovering and developing innovative multi-functional protein-based therapeutics, including bi-specific antibodies and drug conjugates for the treatment of... Read More
Allena’s oxalate decarboxylase to treat paediatric hyperoxaluria gets US FDA orphan drug status
Allena Pharmaceuticals, Inc., a specialty biopharmaceutical company focused on developing and commercialising innovative, non-systemic, oral protein therapeutics to treat metabolic and orphan... Read More
Marinus Pharmaceuticals receives FDA Orphan Drug status for ganaxolone IV to treat status epilepticus
Marinus Pharmaceuticals, Inc, a biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug designation to the... Read More
FDA approves Farydak for treatment of multiple myeloma
The U.S. Food and Drug Administration today approved Farydak (panobinostat) for the treatment of patients with multiple myeloma. Overview of Multiple Myeloma... Read More