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The FDA upheld the De Novo denial for DrugSorb-ATR, a product of CytoSorbents. Phillip Chan serves as the company's CEO.

7 reports, 4 independent Updated Sep 4
Gone quiet Reached 2 outlets in its first 24 hours
Reports
7
Developments
4
Repetition
43%

New informationRepeats or wire copies

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What happened

Well supportedReported by 4 independent outlets

The FDA upheld the De Novo denial for DrugSorb-ATR, a product of CytoSorbents. Phillip Chan serves as the company's CEO.

Who's involved

What this event is mainly about
FDACytosorbentsPhillip Chan

How it developed

Newest first. Tap a step to see who reported it.
  1. Cytosorbents CEO Phillip Chan attended a conference in New York City.1 source
  2. Cytosorbents reports sales decline in Germany due to smaller sales force.1 source
  3. FDA upholds De Novo denial for CytoSorbents' DrugSorb-ATR; Phillip Chan is CEO.1 source
  4. CytoSorbents appealed the FDA's De Novo denial for DrugSorb-ATR, a product used for patients on AstraZeneca's Brilinta.

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Coverage

Newest first; wire copies grouped
  • finanznachrichten.de
  • prnewswire.com
  • PR NewswireCytoSorbents Updates U.S. FDA Regulatory Status of DrugSorb-ATR FDA appeal decision found no issues with DrugSorb-ATR device safety but upheld the De Novo denial, and proposes a potential path forwar
  • Zacks Small Cap ResearchCTSO: CytoSorbents Announces the De Novo denial on DrugSorb-ATR was upheld by the FDA. However, a Path to Approval Was Also Provided by the Agency. By Thomas Kerr, CFA NASDAQ:CTSO READ THE FULL CTSO
  • Unknown outlet
  • Unknown outlet
1 more outlet ran the same wire story