Genzyme said in a Sanofi statement it had received an FDA 'complete response letter', to which it would appeal. Its president and chief executive was " extremely disappointed with the outcome of ...

Genzyme ran into a snag in April when the US Food and Drug Administration (FDA) rejected its application to produce Myozyme (alglucosidase alfa, rhGAA) in its 2,000–liter-scale facility under ...

Sanofi unit Genzyme has fallen foul of the Association of the British Pharmaceutical Industry's Code of Practice over claims that switching patients to its Fabry disease therapy Fabrazyme from ...

March 4, 2025 -- The FDA has approved the first new clot-busting drug in nearly 30 years, offering a faster way to dissolve blood clots in adults who suffer a stroke. The treatment ...

What's more, FDA and Health Canada have granted expanded ... know the differences between stem cell products,” he says. Genzyme and Osiris' partnership hinges heavily on Prochymal (Nat.

Chesbrough, Henry W., and Clarissa Ceruti. "Genzyme: Engineering the Market for Orphan Drugs." Harvard Business School Case 602-147, March 2002. (Revised May 2002.) ...