The FDA has approved a supplement to expand the indication for Lumizyme (alglucosidase alfa), from Genzyme/Sanofi. Lumizyme manufactured at the...
FDA approved Lumizyme (alglucosidase alfa) for late onset Pompe Disease subject to a risk evaluation and mitigation strategy (REMS) and...
Amicus Therapeutics has announced positive preliminary results from all 4 dose cohorts in a Phase II study (Study 010) to...
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nexviadyme,(Lumizyme in the US) intended for the treatment of glycogen storage disease type II (Pompe disease). The applicant for this medicinal product is Genzyme Europe BV.