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AxoGen (AXGN)
NASDAQ:AXGN
Processed Nerve Allograft (Human), Collagen Nerve Cuff
Peripheral Nerve Discontinuities
Phase III
Completed
Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair
Mar 04, 2013
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Processed Human Nerve Tissue Scaffold
Prostate Cancer, Peripheral Nerve Injury, Radical Prostatectomy, Nerve Reconstruction, Cavernous Nerve Injury
Phase IV
Completed
Study of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer
Aug 04, 2009
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does AxoGen (AXGN) have in its pipeline
AXGN is currently developing the following drugs: Processed Nerve Allograft (Human), Collagen Nerve Cuff, Processed Human Nerve Tissue Scaffold. These drug candidates are in various stages of clinical development as the company works toward FDA approval.