Kyowa Hakko Kirin, Orexo's partner, has filed a new drug application (NDA) seeking Japanese approval for KW-2246 as cancer pain medication. The sublingual formulation of fentanyl earlier gained approval in US, EU and Canada as cancer ...
Tags: new drug application, cancer pain medication, pharmaceutical product
Bayer HealthCare has submitted has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its regorafenib drug. The oral multi-kinase inhibitor regorafenib is used for the treatment of metastatic and ...
Tags: NDA, FDA, inhibitor, metastatic, GIST
Navidea Biopharmaceuticals has reported a net loss attributable to common stockholders of $9.12m, or $0.09 per share, for the third quarter ended 30 September 2012 compared to a net income attributable to common stockholders of $19.81m, or ...
Tags: Navidea Biopharmaceuticals, common stockholders, radiopharmaceutical
Janssen Research & Development company has submitted bedaquiline (TMC207) new drug application (NDA) to the US Food and Drug Administration (FDA) for approval. Bedaquiline,an investigational drug administered orally,is used as part of ...
Tags: FDA, new drug application, investigational drug, pulmonary
AVEO Oncology and Astellas Pharma have announced FDA acceptance of tivozanib new drug application(NDA)filing for the treatment of advanced renal cell carcinoma(RCC). According to the development and commercialization deal signed between ...
Tags: AVEO Oncology, Astellas Pharma, FDA, RCC, NDA
Keryx Biopharmaceuticals has reported a net loss of $5.47m, or $0.08 per share, for the third quarter ended 30 September 2012 compared to a net loss of $10.25m, or $0.15 per share, for the third quarter ended 30 September 2011. Operating ...
Tags: Net Loss, Biopharmaceuticals, top-line data
Forest Laboratories and Adamas Pharmaceuticals have collaborated for the development of a fixed dosed combination (FDC) of Namenda XR and donepezil HCl for Alzheimer's dementia in the US. The company expects to launch the FDC that will be ...
BioDelivery Sciences International, a developer of drug delivery technologies, and Endo Health Solutions have started enrolling patients for its Phase 3 clinical program of BEMA Buprenorphine, designed as a treatment for moderate to severe ...
Tags: BioDelivery Sciences International, Endo Health Solutions
Hemispherx Biopharma has filed an amended NDA with ANMAT (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica) for the use of Alferon N injection to treat Hepatitis C patients in Argentina. ANMAT has previously approved ...
Tags: Hemispherx Biopharma, Amended NDA, Alferon N Injection, ANMAT
The US Food and Drug Administration (FDA) has accepted GeNO's filing of new drug application (NDA) for GeNOsyl MVG-2000 nitric oxide delivery system. GeNOsyl nitric oxide is a vasodilator which is indicated for the treatment of term and ...
Tags: GeNOsyl nitric oxide, FDA
The FDA has approved Stiefel's new drug application (NDA) for Fabior (tazarotene) foam, 0.1%, to treat acne vulgaris in patients 12 years of age and older. North America Dermatology vice president Jean-Christophe May said, "Stiefel is ...
Tags: Stiefel NDA, Tazarotene foam, Medicine
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. ...
The US Food and Drug Administration (FDA) has accepted to review Ferring Pharmaceuticals' new drug application (NDA) of controlled release misoprostol vaginal insert (MVI) for decreasing time to vaginal delivery in women with an unfavorable ...
Furniture retailer IKEA has recalled a track lighting system after a ground connection in the product was found to be faulty. The defect, which could pose an electric shock hazard has been found in the IKEA 365 + SÄNDA track, 28” ...
Tags: track light
The US FDA has granted priority review designation to Bayer HealthCare's new drug application (NDA) filed for regorafenib to treat patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard ...
Tags: US FDA, Bayer HealthCare, NDA