Highlights:
- Veloxis’ Marketing Authorization Application (MAA) to market Envarsus® (formerly LCP-Tacro™) for the prevention of organ rejection in kidney transplant patients in the European Union remains under review with the European Medicines Agency (EMA). The company expects the decision from the European Union in 2014.
- Preparations continue for the submission of a New Drug Application (NDA) for Envarsus® to the US Food and Drug Agency (FDA) in late 2013.
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