- A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
GH Research PLC is addressing the FDA's clinical hold on its IND application.
4 reports, 2 independent
Updated Sep 2
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New informationRepeats or wire copies
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What happened
GH Research PLC is addressing the FDA's clinical hold on its IND application.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.- The FDA requested additional data regarding rat histology findings from a company, with updates being provided from Dublin.Sub-event
GH Research PLC is addressing an FDA clinical hold on its IND application.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 removed the clinical hold on Arbutus Biopharma Corporation's IND application, allowing potential clinical development.
- FDA placed a clinical hold on the drug application submitted by Bright Minds Biosciences Inc.
- The FDA requested additional clinical data from Unicycive Therapeutics.
- Litigation regarding FDA approval process.
- NIH is funding research conducted by the National Cancer Institute (NCI) toward an FDA Investigational New Drug (IND) application.
Coverage
Newest first; wire copies grouped- Insider MonkeyGH Research PLC (GHRS) Reports 73% Remission in Phase 2b Depression Trial We recently compiled a list of the 13 Best Psychedelic Stocks to Invest in Now. GH Research PLC stands ninth among them. GH R
- GlobeNewswireGH Research Reports Second Quarter 2025 Financial Results and Provides Business Updates Global pivotal program initiation on track for 2026 Engagement with FDA on GH001 IND complete response ongoing
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