Xylarex is a novel oral solution intended to be administered daily to reduce the number of ear infections children experience. The primary ingredient in Xylarex has also been
Fermiscan business update Commercialisation of the fermiscan breast cancer test in Australia is on plan Completion of a large scale (2,000 patient) clinical trial program in May 2008
In the complete response letter the FDA raised a number of issues relating to the interpretation of the efficacy data contained in the Silenor new drug application (NDA)
The decision to suspend the Symmetry trial was based on the results of an analysis by the independent Data Monitoring Committee (DMC) which identified safety concerns, including an
The acquisition of AMO is expected to enhance and strengthen Abbott’s diverse mix of medical device businesses and give it a leadership position in the eye care market.
Highlights Sales revenues of NOK33.2 million in Q4 (+41%) Profit of NOK-9.4 million in Q4, up from NOK-16.3 million in Q4 2007 Sales revenues of NOK100.9 million in
According to the company, this represents the first FDA clearance for Nimbus – a technology that is so unique and that it was put through FDA’s de novo
Also, in a separate action, the FDA issued a class-wide requirement for all manufacturers of metoclopramide in the US to provide a risk evaluation and mitigation strategy (REMS)
Corporate Update During 2008, we implemented our restructuring plan to significantly reduce the rate at which we use our cash and to focus our efforts on opportunities that
The approval of Apidra SoloSTAR follows the approval and launch of Lantus SoloSTAR (insulin glargine (rDNA origin) injection) in 2007. Apidra SoloSTAR is expected to be available in
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