The trial’s primary purpose is to evaluate the safety and effectiveness of the Formula Balloon Expandable Stent for the treatment of renal artery atherosclerosis against well-established performance data.
In a letter to the European Medicines Agency (EMEA) on behalf of Bioenvision, Genzyme states that the withdrawal is based on the EMEA’s Committee for Medicinal Products for
The application, known as a type II variation, was submitted to European regulatory authorities in October 2007. This Committee for Medicinal Products for Human Use (CHMP) positive opinion
The FDA will take action on its application in late 2008. Sumatriptan DosePro (formerly known as Intraject sumatriptan) utilizes Zogenix’s proprietary DosePro needle-free drug delivery system to subcutaneously
GI-4000-03 is a an open-label consolidation therapy trial sponsored by Memorial Sloan Kettering Cancer Center (MSKCC) to evaluate the GI-4000 Tarmogen (targeted molecular immunogen) in subjects with non-small
Fosphenytoin Sodium Injection is a prodrug of Phenytoin Sodium and is indicated in the short term use for the prevention and control of generalized seizures occurring during neurosurgery.
This is an important step forward in the FDA’s plans to hire and place FDA staff in China over the next 18 months. In addition, the FDA will
Golimumab, Centocor’s and Schering-Plough’s next-generation human anti-TNF-alpha monoclonal antibody, is being studied as an every four week subcutaneous injection and an intravenous (IV) infusion therapy. Pending regulatory approval
The Phase I study will evaluate the safety, tolerability and pharmacokinetic profile of AEG33773 using a randomized, double blind, placebo controlled, single ascending dose design in healthy male
The system is based on a miniature 3.4 mm distal stereoscopic 3D camera targeting Minimal Invasive laparoscopic and endoscopic Surgery. Visionsense’s stereoscopic 3D camera enables and enhances MIS
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