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 ...
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 ...
BMS refiled quickly, but was given an FDA action date of 27 March 2021 ... for example in the wake of Sanofi’s takeover of Genzyme in 2011, which also included a CVR tied to the approval ...
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 ...
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 ...
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