The FDA rejected the biologics license application submitted by Ultragenyx Pharmaceutical.
3 reports, 2 independent
Updated Jul 14
Gone quiet
Reached 2 outlets in its first 24 hours
- Reports
- 3
- Developments
- 2
- Repetition
- 33%
New informationRepeats or wire copies
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What happened
The FDA rejected the biologics license application submitted by Ultragenyx Pharmaceutical.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.FDA rejected Ultragenyx Pharmaceutical's biologics license application.1 source
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The entities involved
- FDA
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Ultragenyx Pharmaceutical
biopharmaceutical company based in Novato, California, United States
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Coverage
Newest first; wire copies grouped- Insider MonkeyUltragenyx (RARE) Falls 26% as New Treatment Fails to Get FDA Green Light Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) is one of the stocks drowned heavily. Are you holding any? Ultragenyx fell by 26
- GlobeNewswireUltragenyx Receives Complete Response Letter from FDA for UX111 AAV Gene Therapy to Treat Sanfilippo Syndrome Type A (MPS IIIA) Complete Response Letter (CRL) cited specific chemistry, manufacturing
- Unknown outlet