BioCentury
ARTICLE | Clinical News

Taliglucerase alfa regulatory update

December 6, 2010 8:00 AM UTC

Pfizer submitted an MAA to the European Medicines Agency (EMA) for taliglucerase alfa to treat Gaucher's disease. An NDA for the plant cell-expressed recombinant form of human glucocerebrosidase (GCase) is under FDA review with a Feb. 25, 2011, PDUFA date. ...