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®
Janssen-Cilag (Janssen), a subsidiary of Johnson & Johnson pharmaceutical firm, has submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) for the approval of once daily oral drug ibrutinib for the ...
Tags: Blood Cancer Medicine, Medicine
Collegium Pharmaceutical, a specialty pharmaceutical company, has announced that a patent has been issued by the US Patent and Trademark Office (USPTO) covering its Oxycodone DETERx formulation. Additionally, an application has been ...
Specialty pharmaceutical company Iroko Pharmaceuticals has announced the FDA acceptance for New Drug Application (NDA) filing of lower dose submicron Indomethacin, a non-steroidal anti-inflammatory drug. The proposed indication of the ...
Tags: FDA Acceptance, NDA Filing
The US Food and Drug Administration (FDA) has accepted to review Iroko Pharmaceuticals New Drug Application (NDA) for lower dose submicron diclofenac, a non-steroidal anti-inflammatory drug (NSAID), with a proposed indication of treatment ...
Tags: FDA, Pharmaceuticals, Medicine
The US Food and Drug Administration (FDA) has accepted to review Antares Pharma's new drug application (NDA) of OTREXUP, designed for the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis. OTREXUP ...
The US Food and Drug Administration (FDA) has accepted to review Sanofi's new drug application (NDA) of lixisenatide, a once-daily a glucagon-like peptide-1 receptor agonist (GLP-1 RA), for the treatment of adults with type 2 diabetes ...
Japan Tobacco (JT), Keryx Biopharmaceuticals' Japanese partner, has filed a new drug application (NDA) for the marketing approval of Ferric Citrate (Zerenex) in Japan for the treatment of hyperphosphatemia in chronic kidney disease (CKD) ...
Tags: Ferric Citrate, Tobacco, CKD, Pharmaceutical
Takeda Global Research & Development Center and Lundbeck have announced the FDA acceptance of vortioxetine new drug application (NDA) filing for major depressive disorder. The companies have also announced the proposal of Brintellix as ...
Tags: FDA, new drug application, NDA
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 ...
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
Exelixis has completed the submission of new drug application (NDA) for cabozantinib as a treatment for progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC) patients, with the FDA. Cabozantinib is ...
Tags: submission of new drug application, FDA, pharmaceutical product