The FDA and Intellia Therapeutics are preparing a regulatory filing for product approval.
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Updated sep 8
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How it started
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What happened
The FDA and Intellia Therapeutics are preparing a regulatory filing for product approval.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.- Intellia Therapeutics is seeking FDA approval for its drug Lonvo-Z.Sub-event
Intellia expects the FDA to accept its rolling BLA filing.1 source
- FDA reviewed protocol amendment and interim safety data for a company's product.Sub-event
FDA and Intellia Therapeutics are preparing a regulatory filing for product approval.1 source
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The entities involved
- FDA
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Intellia Therapeutics
It is a biotechnology company developing biopharmaceuticals using a CRISPR gene editing system.
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