FDA Events for NeoGenomics (NEO)
This section highlights FDA-related milestones and regulatory updates for drugs developed by NeoGenomics (NEO).
Over the past two years, NeoGenomics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
circulating. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
circulating tumor DNA - FDA Regulatory Timeline and Events
circulating tumor DNA is a drug developed by NeoGenomics for the following indication: For Advancing Cancer Diagnostics and Personalized Treatment.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- circulating tumor DNA
- Announced Date:
- September 11, 2024
- Indication:
- For Advancing Cancer Diagnostics and Personalized Treatment
Announcement
NeoGenomics, Inc announced that will present three studies at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, September 13-17 (booth #438). NeoGenomics' data offers key insights into circulating tumor DNA (ctDNA) analysis and next-generation sequencing (NGS), focusing on their role in early diagnosis and treatment optimization.
AI Summary
NeoGenomics, Inc. will present three important studies at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, from September 13-17 at booth #438. The studies highlight significant advances in circulating tumor DNA (ctDNA) analysis and next-generation sequencing (NGS), which help detect cancer early and optimize treatment. Researchers are using these tools to identify cancers in high-risk patients and guide personalized therapies. One study on non-small cell lung cancer examines ctDNA to spot early signs of relapse, while another evaluates ctDNA as a marker in high-risk melanoma patients. A third study shows that testing for multiple gene fusions using NGS can find more patients eligible for targeted therapies compared to more limited tests. Overall, the data underscores the growing potential of advanced molecular diagnostics for earlier cancer detection and improved treatment decisions.
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NeoGenomics FDA Events - Frequently Asked Questions
As of now, NeoGenomics (NEO) has not received any FDA approvals for its therapy in the last two years.
In the past two years, NeoGenomics (NEO) has reported FDA regulatory activity for circulating tumor DNA.
The most recent FDA-related event for NeoGenomics occurred on September 11, 2024, involving circulating tumor DNA. The update was categorized as "Presentation," with the company reporting: "NeoGenomics, Inc announced that will present three studies at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, September 13-17 (booth #438). NeoGenomics' data offers key insights into circulating tumor DNA (ctDNA) analysis and next-generation sequencing (NGS), focusing on their role in early diagnosis and treatment optimization."
Currently, NeoGenomics has one therapy (circulating tumor DNA) targeting the following condition: For Advancing Cancer Diagnostics and Personalized Treatment.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:NEO) was last updated on 7/12/2025 by MarketBeat.com Staff
