Regulatory Affairs Professionals Society

Industry groups seek more flexibility for DHTs in clinical trials

Industry groups have asked the US Food and Drug Administration (FDA) to provide more clarity about its regulatory approach to ...
FierceBiotech

First FDA IND Milestone Achieved Using Human Vascularized Organoid Efficacy Data

World’s First IND Approval in Oncology Based Solely on Human Vascularized Organoid Efficacy Data Confirms Shift Toward Human-Relevant Preclinical Testing SAN DIEGO, Calif. – October 27, 2025 – ...
Morningstar

Pentixapharm Receives FDA "Study May Proceed" Letters for Dual Theranostic INDs in CXCR4-Based Hemato-Oncology Program

U.S. Investigational New Drug (IND) applications for radiotheranostic pair PentixaFor and PentixaTher became active following completion of the FDA 30-day review period. Proposed phase I/II trial ...
EurekAlert!

Insilico Medicine receives IND approval from FDA for ISM8969, an AI-empowered potential best-in-class NLRP3 inhibitor

Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) paves the way for ISM8969 clinical study in the United States. The Phase I clinical trial aims to evaluate ...
Medical Device and Diagnostic Industry (MD+DI)

FDA Adds New Submission Category in Human Factors Guidance Shake-Up

FDA revises 2022 human factors guidance with new risk-based categories, device modification examples, and 60-day ...
Nasdaq

Quantum BioPharma Submits Investigational New Drug (IND) Application to United States Food and Drug Administration (FDA) for Lucid-MS Phase Two Clinical Trial in Multiple Sclerosis

TORONTO, April 01, 2026 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (“Quantum BioPharma” or the “Company”), a biopharmaceutical company dedicated to building a ...