- A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
A clinical trial site is located in West Haven, Rhode Island, with FDA rejection influencing the trial design.
1 report, 1 independent
Updated Jun 30
AI-generated analysis. Brind wrote this summary from the reports listed below. It can be wrong. Each section says how much you can rely on it, and the sources are linked so you can check.
What happened
A clinical trial site is located in West Haven, Rhode Island, with FDA rejection influencing the trial design.
Who's involved
What this event is mainly aboutKeep 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
- FDA
-
VA Connecticut Healthcare System
healthcare organization in West Haven, United States
Nothing else this week.
-
Rhode Island
state of the United States of America
Related events
- Lakefront, in collaboration with Gilead, received Orphan Drug Designation from the FDA for gamgertamig, with trials active globally.
- FDA issued a partial clinical hold on trials involving Biohaven Ltd. on September 11, 2026.
- Capricor Therapeutics is seeking regulatory approval from the FDA for clinical trials and has listed on the Nasdaq stock exchange, with a law firm based in New York City involved.
- EyePoint Pharmaceuticals developed its LUCIA trial program in alignment with the FDA, with enrollment noted in Lugano.
- BioXcel Therapeutics received FDA approval for its drug and announced results from New Haven.