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 ...

The US Food and Drug Administration has delayed granting full approval of Novavax’s Covid-19 vaccine despite it being on track to be cleared until Tuesday afternoon, a person familiar with the ...

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 has settled a long-running dispute with shareholders in the biotech Genzyme, who claimed the big pharma deliberately held back development of a multiple sclerosis drug to avoid payments ...

WASHINGTON − The Supreme Court on Wednesday unanimously overturned a lower court’s decision that the Food and Drug Administration incorrectly blocked companies from selling fruit- and candy ...

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.) ...