The Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has recommended Orphan Drug Designation (ODD) for Erytech Pharma's investigational product Enhoxy. The drug, which is used to treat sickle cell ...
Tags: orphan drug designation, Erytech product, debilitating disease
Raptor Pharmaceutical has announced FDA acceptance of new drug application (NDA) for Cysteamine Bitartrate delayed-release capsules (RP103) for the potential treatment of nephropathic cystinosis. RP103 gained standard review designation ...
Tags: nephropathic cystinosis, FDA acceptance, NDA submission
Ligand Pharmaceuticals partner GlaxoSmithKline has submitted regulatory applications in the US and European Union for the use of eltrombopag (Promacta/Revolade) to increase platelet counts in patients with hepatitis C. A supplemental ...
The European Commission (EC) has awarded a conditional marketing authorization approval for Cell Therapeutics' Pixuvri (pixantrone) as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive ...
Tags: marketing authorization, pharmaceutical product, Pixuvri
Dynavax Technologies has submitted a US Biologics License Application (BLA) to the FDA for HEPLISAV, an investigational adult hepatitis B vaccine. In Phase III trials, HEPLISAV demonstrated higher and earlier protection with fewer ...
The Austrian Agency for Health and Food Safety has issued marketing authorization to pSivida ILUVIEN for the treatment of vision impairment associated with chronic diabetic macular edema (DME). The injectable, sustained-release ...
Tags: Marketing Authorization, reatment of vision impairment, clinical product