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 FDA issued a warning letter to Sanofi regarding significant manufacturing violations at its Genzyme Corporation Facility in Framingham, Mass. The letter, dated Dec. 16, 2024, and amended Jan ...

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 ...

Also Read: Sanofi Genzyme Facility Draws FDA Criticism Over Alleged Quality Lapses An independent data monitoring committee ...

On Jan. 15, 2025, a warning letter was sent to Sanofi stating that FDA inspectors found irregularities with the facility's bioreactor, the vessel used to grow organisms and cells. According to the ...

Genzyme became a subsidiary of Sanofi and kept ... Biggest Boston biotech news coming out of JPM 2025 Hologic gets FDA warning regarding implantable devices Hologic gets FDA warning regarding ...

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.

But the Genzyme shareholders said Sanofi slowed development ... In Lemtrada’s case payouts were cut because of an initial FDA rejection, and eventual approval in 2014, several months too late ...