FDA extends Arzerra's review period for chronic lymphocytic leukaemia
16 June 2009
Malini Guha
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16 June 2009
Malini Guha
malini.guha@informa.com
The US FDA has extended by three months the review period for GlaxoSmithKline/ Genmab's anti-CD20 monoclonal antibody drug Arzerra (ofatumumab), which the companies filed in January for its first indication, chronic lymphocytic leukaemia (CLL).
The BLA was submitted on January 30th and was...
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