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 ...

IND Filing and Concurrent RMAT Request Position XytriX™ as a Potential Breakthrough Biotherapeutic for More Than 500 Million People Living with Osteoarthritis Our concurrent request for RMAT ...

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 ...

Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or “the Company”), a biotechnology company pioneering the development of targeted genetic medicines, today announces that it has received ...

FDA IND clearance permits a U.S. phase 2 registration-oriented trial of FG001 in high-grade glioma, with first-patient-in expected during Q2 2026. Fluorescence-guided surgery with FG001 aims to ...