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

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 ...

Half of patients who used delgocitinib cream for chronic hand eczema had a profound response, and a third who stopped ...

Two months later, Orchard won FDA approval for its gene therapy in ... in 2018 when he ended a 14-year spell at Sanofi and its Genzyme unit to lead Orchard’s commercialization strategy and ...

Sanofi SA (NASDAQ:SNY) and Johnson & Johnson (NYSE:JNJ) have discontinued the E.mbrace phase 3 study evaluating a vaccine candidate for extraintestinal pathogenic E. coli. The E.mbrace study is a ...

A new analysis provides substantial evidence that paramagnetic rim lesions drive disability in MS and are targetable with a ...

Genzyme continued to drive growth for Sanofi ... analysts predicting sales of several billion dollars a year for the drug. Sanofi said the consolidation of Bioverativ, the haemophilia specialist ...

Bempikibart demonstrated positive, durable responses among patients with severe to very severe alopecia areata, according to ...

The oral drug is an alternative to the infused enzyme replacement therapy that is current standard of care - Sanofi/Genzyme’s Fabarazyme (agalsidase beta). Already approved in Europe ...

In May 2020, the companies filed an application with the U.S. Food and Drug Administration (FDA) seeking the accelerated approval of PRX-102, given at a dose of 1 mg/kg every other week ...

Also Read: Sanofi Genzyme Facility Draws FDA Criticism Over Alleged Quality Lapses An independent data monitoring committee (IDMC) conducted a scheduled review of the E.mbrace phase 3 study.

Genzyme Corporation, which was acquired by Sanofi in April 2011 ... decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or ...