FDA Rejects Ultragenyx's Gene Therapy Applications
TL;DR
The FDA has declined to approve Ultragenyx's gene therapy, highlighting ongoing challenges in biotech approvals, while other news includes AstraZeneca's promising hypertension drug and insights into FDA commissioner Marty Makary's initiatives.
- FDA declines to approve Ultragenyx gene therapy STAT
- Ultragenyx takes another hit as FDA snubs AAV gene therapy over manufacturing issues Fierce Pharma
- US FDA declines to approve Ultragenyx's gene therapy for rare genetic disorder Reuters
- Ultragenyx gets FDA complete response letter for Sanfilippo gene therapy FirstWord Pharma
- Ultragenyx receives complete response letter for UX111 BLA Yahoo Finance
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