Revelation Biosciences Reaches Agreement with FDA on Gemini Approval Pathway for AKI

We are grateful for the collaborative feedback from FDA on the Gemini program, which provides us a clear and expedient path forward for seeking approval of Gemini as a treatment for AKI,” said, James ...
Seeking Alpha

Adaptive Clinical Protocol Design for Phase II MPox Clade I Treatment with a Novel Broad-Spectrum Drug NV-387 is Almost Complete, Reports NanoViricides

SHELTON, CT / ACCESS Newswire / July 14, 2025 / NanoViricides, Inc. (NNVC), a publicly traded company (NYSE Amer.:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development ...
Seeking Alpha

Adial Pharmaceuticals Provides Business Update Following Favorable Comments from FDA End-of-Phase 2 (EOP2) Meeting for AD04

GLEN ALLEN, Va., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the ...
Applied Clinical Trials Online

ACT Brief: eSource Moves Toward AI-Enabled Validation, Outsourcing Models Shift Toward Flexibility, and Robust Trial Design Becomes Mission Critical

This is the Applied Clinical Trials Brief —your fast track to the latest insights shaping clinical operations and drug development.
Benzinga.com

Adial Pharmaceuticals Highlights Favorable Comments From FDA Meeting For Lead Program In Alcohol Use Disorder

Adial Pharmaceuticals, Inc. (NASDAQ:ADIL) on Tuesday received the final meeting minutes from its End of Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration (FDA) held in July. The ...
Morningstar

Oncolytics Biotech® to Engage FDA for Potential Registration-Enabled Study in First-Line Pancreatic Cancer with Goal to Launch Trial Activities by Year-End

Clear regulatory path and strong survival data in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) support accelerated strategy to drive shareholder value and partnership opportunities ...
The Bulletin

IDDI Strengthens Position as Contract Research Organization with Advanced Clinical Trial Design Solutions

The International Drug Development Institute (IDDI) is reinforcing its position as a contract research organization by introducing innovative clinical trial design and analysis solutions that are ...
ascopubs.org

Using Dose-Escalation and -Expansion Cohort Study as Pivotal Trial for Targeted Anticancer Drug Approval

BRCA1-Associated Protein 1 and Enhancer of Zeste Homolog 2: Pathway Interaction and Therapeutic Intervention in Breast Cancer, Mesothelioma, and Lymphoma Early-phase clinical trials (EPCTs) have been ...
Nasdaq

Adial Pharmaceuticals Provides Business Update Following Favorable Comments from FDA End-of-Phase 2 (EOP2) Meeting for AD04

FDA Minutes Reflect Constructive Dialogue and Successful Meeting Outcome with Alignment on Upcoming Phase 3 Clinical Trial Design for AD04 In Alcohol Use Disorder GLEN ALLEN, Va., Sept. 16, 2025 ...