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 ...
Morningstar

FDA Clears FluoGuide's IND for FG001 in High-Grade Glioma; U.S. Clinical Trial Remains on Track

COPENHAGEN, DENMARK / ACCESS Newswire / February 20, 2026 / FluoGuide A/S (STO:FLUO) ("FluoGuide" or the "Company"), a biotech company maximizing surgical outcomes in oncology by lighting up cancer, ...
Tallahassee Democrat

TriCelX Files IND with FDA & Concurrently Requests RMAT Designation for XytriX™ in the Treatment of Knee Osteoarthritis

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 ...
Times Argus

Telomir Pharmaceuticals Submits IND to FDA for Telomir-1 (Telomir-Zn) in Advanced and Metastatic Triple-Negative Breast Cancer

First-in-class metal-modulating epigenetic therapy targeting iron-dependent pathways with preclinical efficacy and a favorable GLP safety profile. MIAMI, FL / ACCESS Newswire / March 31, 2026 / ...