JD Supra

Biological Products Regulation Part 3: Unlocking Reference Product Exclusivity: What Sponsors Need to Know

Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number ...
Nasdaq

FDA Accepts for Review Medexus's IXINITY Supplemental Biological License Application for Pediatric Patients

Expanded indication would cover patients 12 years of age or younger, a population that comprises approximately one in three patients treated for hemophilia B in the United States "Approximately one ...
Seeking Alpha

Longeveron® Announces Positive Type C Meeting with U.S. FDA Regarding Pathway to BLA for Lomecel-B™ in Hypoplastic Left Heart Syndrome (HLHS)

On-going Phase 2b clinical trial (ELPIS II) deemed pivotal and, if positive, acceptable for Biological License Application (BLA) submission for potential full traditional approval Alignment with FDA ...

Longeveron Announces FDA Grants Type C Meeting Ahead of Data Readout for Pivotal Phase 2 Clinical Trial (ELPIS II) Evaluating Treatment for Hypoplastic Left Heart Syndrome (HLHS)

ELPIS II top-line trial results are anticipated in the third quarter of 2026Laromestrocel Biological License Application (BLA) submission for ...