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
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- Reports
- 7
- Developments
- 4
- Repetition
- 43%
New informationRepeats or wire copies
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What happened
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 aboutHow it developed
Newest first. Tap a step to see who reported it.Cytosorbents CEO Phillip Chan attended a conference in New York City.1 source
Cytosorbents reports sales decline in Germany due to smaller sales force.1 source
FDA upholds De Novo denial for CytoSorbents' DrugSorb-ATR; Phillip Chan is CEO.1 source
- CytoSorbents appealed the FDA's De Novo denial for DrugSorb-ATR, a product used for patients on AstraZeneca's Brilinta.
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The entities involved
- FDA
-
Cytosorbents
company
Nothing else this week.
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Phillip Chan
researcher
Nothing else this week.
Related events
- Atrium and Bristol-Myers Squibb received IND clearance from the FDA and obtained a No Objection Letter for Canadian sites.
- Cytosorbents regained the minimum bid price requirement of $1.00 per share on Nasdaq and is advancing its DrugSorb-ATR product toward FDA regulatory approval.
- The FDA has questioned promotional materials related to an investigational drug from Alar Pharmaceuticals.
- Future sales of a product are contingent upon obtaining the necessary FDA registration and labeling, while the state simultaneously announces actions to remove regulatory barriers.
- BioXcel Therapeutics received FDA approval for its drug and announced results from New Haven.
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
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