- A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
The FDA has issued a Major Amendment regarding AxoGen's submission on August 25, 2025.
2 reports, 2 independent
Updated Sep 11
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What happened
The FDA has issued a Major Amendment regarding AxoGen's submission on August 25, 2025.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.AxoGen acquires BioCircuit's FDA-approved NerveTape device.1 source
FDA deemed AxoGen's submission a Major Amendment.1 source
Keep 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
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- Litigation regarding FDA approval process.
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- FDA policy proposal affects the operations of AI, Inc.
- FDA approval expands patient access to therapies for ACCORD.
Coverage
Newest first; wire copies grouped- finanznachrichten.de
- GlobeNewswireAxogen Provides Update on FDA Review Timeline for Avance Nerve Graft FDA PDUFA goal date extended by three months ALACHUA, Fla. and TAMPA, Fla., Aug. 25, 2025 (GLOBE NEWSWIRE) -- Axogen, Inc. (Nasdaq