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 ...
Seattle Genetics, Inc. (Nasdaq: SGEN) today announced that its collaborator, Takeda Pharmaceutical Company Limited (Takeda), has received approval of ADCETRIS (brentuximab vedotin) from the Japanese Ministry of Health, Labour and Welfare ...
RegeneRx Biopharmaceuticals, Inc. (OTC: RGRX) ("the Company" or "RegeneRx") announced that it has received Orphan Drug designation from U.S. FDA's Office of Orphan Products Development (OOPD) for its drug candidate, Thymosin beta 4 ...
Tags: RegeneRx Biopharmaceuticals, Orphan Drug designation, Thymosin beta 4
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
NanoViricides has secured orphan drug designation from the European Medicines Agency (EMA) for its drug candidate DengueCide, for the treatment of dengue and dengue hemorrhagic fever. Dengue fever is a mosquito-borne disease that affects ...
Tags: Nanoviricides Drug
Cornerstone Pharmaceuticals has received the US Food and Drug Administration (FDA) orphan drug designation for its altered energy metabolism directed (AEMD) drug candidate 'CPI-613' for treatment of myelodysplastic syndrome (MDS). MDS is ...
The US Food & Drug Administration (cof Orphan Product Development has granted orphan drug designation for Lumena Pharmaceuticals' LUM001 clinical program. Lumena obtained orphan designation for LUM001 in four rare cholestatic liver ...
Tags: Orphan Drug, Rare Liver Diseases