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 ...

BioMarin's gene therapy pipeline has had setbacks, including a three-year delay in US approval of Roctavian and stalled development of PKU gene therapy BMN 307 as the Food and Drug Administration ...

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. The ...

Fabry Disease Clinical Trial Pipeline Major pharmaceutical companies are working to advance the pipeline space and unlock the future growth ...

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.

Q4 2024 Earnings Call Transcript February 12, 2025 Operator: Good morning. My name is Jennifer and I will be your conference operator today. At this time, I’d like to welcome everyone to the Biogen ...

At this time, I'd like to welcome everyone to the Biogen fourth-quarter and full-year 2024 earnings call and business update. [Operator instructions] Today's conference is being recorded. Thank you. I ...

Sanofi's Genzyme rare diseases division already sells ... which remains the only other FDA-approved therapies for Pompe. The company estimates there are around 3,500 people in the US with both ...

Sanofi paid out $315 million to former Genzyme shareholders in that case, well below the $700 million to $3.8 billion range promised in the CVR. The FDA is set to decide on MSD's Keytruda as ...

I remember years ago when we acquired Genzyme when I was at Sanofi and the ... So we have the LEQEMBI IV maintenance that's now FDA approved. You know, we now have the first patients who are ...

I remember years ago, when we acquired Genzyme when I was at Sanofi and the marketing folks ... So we have the LEQEMBI IV maintenance that's now FDA-approved. We now have the first patients who are ...