RAPS

FDA official offers examples of RWE being used to secure drug approval

An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to ...
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 ...
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

EndoCyclic Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for ENDO-205, a First-in-Class Non-Hormonal Precision Peptide Therapeutic for ...

IRVINE, Calif., March 23, 2026 /PRNewswire/ -- EndoCyclic Therapeutics, a biopharmaceutical company developing precision peptide therapeutics and diagnostics for complex diseases, today announced that ...
Nasdaq

Enveric Biosciences Receives FDA Response and Streamlines Plans for EB-003 IND Submission

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing next-generation neuroplastogenic small molecules to address ...