IND Investigator Responsibilities Performance of FDA-regulated studies using investigational drugs or biologics (i.e., agents that require an IND application/number for human use) creates important ...

The FDA has approved the investigational new drug application of AS1986NS for prostate cancer detection and treatment.

Sangamo Therapeutics announced that the FDA has cleared the investigational new drug application for its ST-503 program, an investigational epigenetic regul ...

CERo Therapeutics (CERO) announces that the U.S. Food and Drug Administration has cleared the Company’s Investigational New Drug ...

CERo Therapeutics (CERO) announces that the U.S. Food and Drug Administration has cleared the Company’s Investigational New Drug Application for Phase 1 clinical trials of its lead compound ...

“FDA IND approval for TB006 is a major achievement ... It is the second most common neurodegenerative condition after Alzheimer’s. The number of people with PD will increase substantially ...

announced today that the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) application for TYRA-300 allowing the company to proceed with a Phase 2 clinical trial ...

Company to conduct a Phase 1 Drug-Drug Interaction Study Phase 2 filing on track for Q1 2025 The DDI study is designed to evaluate the effect of a cytochrome P450 inhibitor and inducer on ALG ...

Phase 2 enabling activities are ongoing, with a planned Phase 2 IND filing in Q1 2025. ALG-000184 has a clear regulatory path endorsed by the FDA and CDE (China) for chronic suppressive therapy ...