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
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
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 ...
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 ...
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 ...
Teva Pharmaceutical and Xenon Pharmaceuticals have announced the FDA orphan drug designation for analgesic XEN402 being developed to treat pain associated with erythromelalgia (EM). The novel chemical entity XEN402 is designed to inhibit ...
Tags: Pharmaceutical, FDA, Orphan Drug
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
The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to SOV Therapeutics' oral testosterone undecanoate, a pro-drug of testosterone, for the treatment of Constitutional Delay of Growth and Puberty (CDGP) in ...
Tags: orphan drug, oral testosterone replacement therapy, FDA
Clinical stage biopharmaceutical company Apogenix's Apocept (APG101) has won FDA orphan drug designation to treat myelodysplastic syndromes (MDS). Apogenix also announced the commencement of Apocept Phase I trial in MDS patients in ...
Tags: FDA, orphan drug, biopharmaceutical
The US FDA has granted Soligenix fast track designation for OrbeShield for the reduction of mortality associated with gastrointestinal acute radiation syndrome (GI ARS). The oral beclomethasone 17,21-dipropionate (oral BDP) earlier ...
Tags: US FDA, Soligenix, fast track designation, OrbeShield
Telik has announced notification of FDA orphan drug designation to ezatiostat HCL (Telintra) for the treatment of myelodysplastic syndrome (MDS). The novel inhibitor of the enzyme glutathione S-transferase P1 1,Telintra activates Jun ...
Tags: orphan drug, ezatiostat HCL, drug
PharmaIN and LAT Pharma have announced the issuance of FDA orphan-drug designation for terlipressin as treatment of ascites due to all etiologies apart from cancer. The companies are developing long-acting PHT101(PGC-C12E-Terlipressin)for ...
Tags: PharmaIN-LAT Pharma ascite therapy, FDA orphan-drug designation, PHT101
CSL Behring has received FDA orphan drug designation for its recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP). The designation was granted for the treatment and prophylaxis of bleeding episodes in ...
Tags: CSL Behring, rIX-FP, hemophilia B
FDA has designated Stratatech's universal human skin substitute, StrataGraft, as an orphan drug for the treatment of partial and full thickness skin burns. As per the orphan drug status, the company will be able to market StrataGraft once ...