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 ...

Merck unveils a $1 billion vaccine manufacturing facility in Durham, North Carolina, expanding its U.S. production and ...

If it’s published, the FDA is expected to propose language noting that “these chemicals are used in certain cosmetic products that are applied to human hair as part of a combination 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 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 ...

Although Genzyme also produces Myozyme (alglucosidase alpha) at the plant, no runs were scheduled during the presumed period of shutdown so supplies of that drug will not be affected. With sales ...

Genzyme Approved by US FDA Stem cell mobilizer Use in combination with G-CSF AMD070 Genzyme Suspended (Phase I/II) HIV A derivative of AMD3100 that can be orally administered. Liver histology ...