The FDA is reviewing the BLA submission from Ultragenyx Pharmaceutical, with Eric Crombez serving as chief medical officer.
5 reports, 4 independent
Updated Oct 7
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- Reports
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- Repetition
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New informationRepeats or wire copies
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What happened
The FDA is reviewing the BLA submission from Ultragenyx Pharmaceutical, with Eric Crombez serving as chief medical officer.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.FDA grants approval for Ultragenyx's drug GENGLYCOS.1 source
FDA has begun reviewing the BLA submission from Ultragenyx Pharmaceutical.1 source
- FDA granted Breakthrough Therapy Designation for Ultragenyx's GTX-102 for Angelman syndrome.
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The entities involved
- FDA
-
Ultragenyx Pharmaceutical
biopharmaceutical company based in Novato, California, United States
Nothing else this week.
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Eric Crombez
researcher
Nothing else this week.
Related events
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- FDA accepts a BLA for biosimilar review and extends its review process to Health Canada.
- BDR Pharmaceuticals filed a lawsuit challenging FDA decisions related to Phathom Pharmaceuticals' drug applications.
- Arthur Caplan questioned the FDA regarding the status of clinical trials in 2006.
- FDA issued a Complete Response Letter (CRL) regarding Disc Medicine, Inc.'s bitopertin program.
Coverage
Newest first; wire copies grouped- proactiveinvestors.com
- GlobeNewswireUltragenyx Initiates Rolling Submission of Biologics License Application (BLA) to U.S. FDA for DTX401 AAV Gene Therapy for the Treatment of Glycogen Storage Disease Type Ia (GSDIa) Company expects to
- Insider MonkeyUltragenyx Pharmaceutical Inc. (RARE) Gets FDA CRL for UX111, Vows Quick Resubmission We recently compiled a list of 11 Best Future Stocks to Buy Now. Ultragenyx Pharmaceutical Inc. stands first on o
- Pharmaceutical TechnologyUltragenyx receives complete response letter for UX111 BLA Ultragenyx Pharmaceutical has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) concerning its biolog
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