RAPS

FDA Guidance Establishes When an IND May Not be Required to Conduct Human Studies

The US Food and Drug Administration (FDA) has released a new final guidance document intended to assist sponsors in determining whether a research study involving human subjects may be conducted ...
newswire

Telomir Pharmaceuticals Announces FDA Clearance of IND for Telomir-Zn in Triple-Negative Breast Cancer

Company Plans to Initiate First-in-Human Phase 1/2 Trial in 1H 2026, Anchored by a Leading U.S. Academic Medical Center. This IND clearance enables the Company to advance Telomir-Zn into clinical ...
Yahoo Finance

Vistagen Receives FDA "Study May Proceed" Letter Under its Refisolone IND Application, Enabling Further Phase 2 Clinical Development for the Treatment of Vasomotor Symptoms ...

SOUTH SAN FRANCISCO, Calif., April 22, 2026--(BUSINESS WIRE)--Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to ...
Medicine Buffalo

Investigational New Drug (IND)

An Investigational New Drug (IND) is a drug or biological drug that has not been approved for general use by the FDA. It is used in a clinical trial to investigate its safety and efficacy. The term ...
RAPS

Best Practices for IND Sponsor Communications: FDA Finalizes Guidance

The US Food and Drug Administration (FDA) last week finalized guidance from 2015 on the best practices for communications between investigational new drug application (IND) sponsors and FDA. The ...