The FDA rejected the biologics license application submitted by Ultragenyx Pharmaceutical.
3 reports, 2 independent
Updated Jul 14
Gone quiet
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- Reports
- 3
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- Repetition
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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
- FDA grants Breakthrough Therapy Designation for GTX-102.
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The entities involved
- FDA
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Ultragenyx Pharmaceutical
biopharmaceutical company based in Novato, California, United States
Nothing else this week.
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- Experimental therapies require approval from the FDA.
- Policymakers are considering ways to influence the drug market, including potential changes to patent rights and the FDA approval process.
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