Published in Drug Week, September 8th, 2006
The company also announced that the European Medicines Agency (EMEA) has accepted the company's request for evaluation of its anticipated Marketing Authorization Application (MAA) for Soliris (eculizumab) in PNH under the Accelerated Assessment procedure. Accelerated Assessment is granted for medicinal products of major therapeutic interest and shortens the timeframe for review by the agency. The company further announced that it is on track for submission of both its anticipated Biological License Application (BLA) for Soliris (eculizumab) in PNH in the United...
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