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
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 ...
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 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
Aerial BioPharma, a biopharmaceutical company, has won FDA orphan drug designation for its narcolepsy drug in development. The issuance of designation from the FDA follows the completion of a Phase IIa study in which N05 demonstrated ...
The US FDA has granted fast track status to Soligenix's SGX203 for the treatment of pediatric Crohn's disease. SGX203 contains an active corticosteroid, beclomethasone 17,21-dipropionate (BDP), that targets local inflamed tissue. ...
Athersys has received FDA orphan drug designation for its proprietary cell therapy, MultiStem, to treat Hurler's syndrome, also known as mucopolysaccharidosis type I or MPS-I. The orphan drug designation provides substantial potential ...
REGENX BioSciences has received FDA orphan drug designation for treatment of familial hypercholesterolemia (HoFH) using NAV rAAV8 vectors. The REGENX program consists of a NAV rAAV8 vector expressing a normal copy of the human ...
Tags: orphan drug designation, familial hypercholesterolemia, clinical study