US-based XOMA Corporation (XOMA) has received Orphan Drug Designation from the US Food and Drug Administration (FDA) for its IL-1 beta modulating antibody 'gevokizumab' for the treatment of pyoderma gangrenosum (PG). Gevokizumab is a ...
Tags: Orphan Drug, Medicine
The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Takeda Pharmaceutical's new drug application (NDA) of Adcetris (brentuximab vedotin) 50mg intended to treat patients with CD30 positive relapsed or refractory hodgkin ...
NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, today announced that the European Commission has granted orphan drug ...
Veloxis Pharmaceuticals A/S (OMX: VELO), today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Envarsus® (formerly ...
Tags: Veloxis Pharmaceuticals, New Drug Application, Envarsus®
The US Food and Drug Administration (FDA) has granted orphan drug status for Kinex Pharmaceuticals' dual src/pre-tubulin inhibitor 'KX02' for the treatment of gliomas, which are the most common and aggressive form of brain cancer. KX02 is ...
Tags: Orphan Drug, Medicine
The US Food and Drug Administration (FDA) has granted orphan drug status for Teva Pharmaceutical's Treanda injection through October 2015 for indolent B-cell non-Hodgkin lymphoma (iNHL) that has progressed during or within six months of ...
The US Food and Drug Administration (FDA) has granted orphan drug designation to Conatus Pharmaceuticals' drug candidate emricasan for the treatment of liver transplant patients with reestablished fibrosis to delay the progression to ...
VBL Therapeutics has secured fast track status from the US Food and Drug Administration (FDA) for its lead oncology drug VB-111, for prolongation of survival in patients with Recurrent Glioblastoma Multiforme (rGBM). VB-111 was already ...
Italy-based Gentium and Link Healthcare announced that defibrotide has been designated as an orphan drug for the treatment of hepatic veno-occlusive disease (VOD). The sponsor of Defibrotide is Link Healthcare, Gentium's exclusive ...
Tags: Gentium, Orphan Drug
The US Food and Drug Administration (FDA) has accepted for review US-based biopharmaceutical firm NPS Pharmaceuticals' supplemental new drug application (sNDA) for Gattex (teduglutide [rDNA origin]) for injection. In the US, Gattex is ...
Tags: FDA, biopharmaceutical
The European Medicines Agency (EMA) has granted an orphan drug status to US-based clinical-stage biotechnology company GlycoMimetics' GMI-1070 (rivipansel sodium), designed to treat vaso-occlusive crisis (VOC) in patients with sickle cell ...
The European Medicines Agency (EMA) has granted an orphan drug status to US-based clinical-stage biotechnology company GlycoMimetics’ GMI-1070 (rivipansel sodium), designed to treat vaso-occlusive crisis (VOC) in patients with sickle ...
Tags: Orphan Drug, Cell Drug
Stemline Therapeutics' SL-401 has won orphan drug designation from the Food and Drug Administration (FDA) for the treatment of aggressive hematologic malignancy blastic plasmacytoid dendritic cell neoplasm (BPDCN). With an orphan drug ...
Tags: Stemline Therapeutic, Orphan Drug
Basilea Pharmaceutica has obtained FDA orphan drug status to isavuconazole, an investigational intravenous and oral broad-spectrum antifungal, for the treatment of invasive aspergillosis. Isavuconazole is being investigated in phase 3 ...
The USFDA has granted orphan drug designation to Pluristem Therapeutics' PLacental eXpanded (PLX) cells to treat aplastic anemia. The failure of hematopoietic stem cells (HSCs) present in the bone marrow to produce red blood cells, white ...
Tags: orphan drug, aplastic anemia, drug