- A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
Intelligent Bio Solutions Inc. sought FDA 510(k) clearance for market expansion.
10 reports, 3 independent
Updated Aug 19
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New informationRepeats or wire copies
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What happened
Intelligent Bio Solutions Inc. sought FDA 510(k) clearance for market expansion.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.Seeking FDA 510(k) clearance for market expansion.1 source
Company seeks FDA approval for screening system.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
- FDA clearance drives market expansion and coverage for NeurAxis, Inc.
- FDA clearance enables market entry into the U.S. for an unnamed company, which is also navigating the long-term regulatory process in Japan.
- FDA granted 510k clearance for the ZEISS CLINIC 360 software solution.
- Modular is seeking FDA clearance for its Pivot product.
- Biocon's subsidiary received FDA approval for a drug in the United States on August 18, 2026.
Coverage
Newest first; wire copies grouped- manilatimes.net
- manilatimes.net
- GlobeNewswireIntelligent Bio Solutions Reports Fiscal 2025 Fourth Quarter and Full Year Results, Highlighting Progress on Planned U.S. Market Expansion, Revenue Growth and Increased Operational Efficiencies Compa
- BenzingaEXCLUSIVE: Intelligent Bio Expects Double Digit Topline Growth In Q4 Intelligent Bio Solutions Inc. (NASDAQ:INBS) reported preliminary fiscal fourth quarter revenue results and selected operational h
- GlobeNewswireIntelligent Bio Solutions Announces Preliminary Fiscal Fourth Quarter Revenue with Double-Digit Sequential and Year-Over-Year Growth and Strong Operational Momentum Company anticipates fiscal fourth
- GlobeNewswireIntelligent Bio Solutions Strengthens FDA 510(k) Package with New Cybersecurity and Performance Data Ahead of Planned U.S. Market Launch FDA response expected within six weeks; Company remains focuse
- GlobeNewswireIntelligent Bio Solutions Inc. Enters Into Agreements to Raise $3.8 Million in Gross Proceeds Proceeds to Fund Completion of the Company’s 510k Filing with the U.S. FDA for its Fingerprint Drug Scree
- BenzingaEXCLUSIVE: Intelligent Bio Solutions' New Data Confirms Ability To Detect Trace Sweat Volumes At Ultra-Micro Level Intelligent Bio Solutions Inc. (NASDAQ:INBS) on Wednesday announced the collection o
- GlobeNewswireIntelligent Bio Solutions to Strengthen FDA 510(k) Submission with New Positive Data Demonstrating Ultra-Precise Fingerprint Sweat Detection and Platform Resilience Data confirms Company’s ability to