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 ...
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 ...
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 ...
Columbia Daily Tribune

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 ...
USA Today

Aspire Biopharma Announces Successful Pre-IND Meeting with FDA for High-Dose Sublingual Aspirin (OTASA)

FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject clinical trial ESTERO, FL / ACCESS Newswire / January 7, 2026 / Aspire Biopharma ...