- A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
Cytiva is conducting gene therapy trials and received FDA approval to continue the trials.
1 report, 1 independent
Updated Aug 21
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What happened
Cytiva is conducting gene therapy trials and received FDA approval to continue the trials.
Who's involved
What this event is mainly aboutKeep exploring
Part of
A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.Also in this story
- A partnership with BARDA has accelerated the development of SCY-247 for the company.
- A company plans to submit regulatory applications to the FDA, EMA, and Australian TGA.
- Approval leads to procurement process initiation.
- UroGen Pharma Ltd., headquartered in Princeton, is seeking FDA approval for its products for the U.S. market.
The entities involved
Related events
- Solid Biosciences received FDA approval for a gene therapy trial on July 9, 2025.
- FDA placed a clinical hold on a gene therapy involving Hunter.
- FDA issued a partial clinical hold on trials involving Biohaven Ltd. on September 11, 2026.
- The FDA reviewed gene therapy applications and provided milestone payments for dosing involving Regenxbio and AbbVie.
- Experimental therapies require approval from the FDA.
Coverage
Newest first; wire copies grouped- Clinical Trials ArenaRocket to relaunch rare disease trial after FDA approval The US Food and Drug Administration (FDA) has given Rocket Pharmaceuticals approval to continue its pivotal Phase II trial of gene therapy RP-