JD Supra

Biological Products Regulation Part 5: Preparing for the FDA’s Pre-License Inspection

In the fifth part of our FDA: Drug & Device Team’s series on biological products regulation, we discuss key considerations for biologics license applications (BLAs) and the Food and Drug ...
Yahoo Finance

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 Toronto, Ontario and ...
techtarget

Vertex and CRISPR Submit BLA for Sickle Cell Disease Treatment

On April 3, 2023, Vertex Pharmaceuticals and CRISPR Therapeutics announced that they submitted Biological License Applications (BLAs) for an investigational treatment using exagamglogene autotemcel ...
Yahoo Finance

Mesoblast's (MESO) GVHD Drug BLA Gets FDA Priority Tag, Stock Up

Melbourne-based biotech, Mesoblast Limited MESO announced the FDA acceptance of the resubmission of its biological license application (BLA) for remestemcel-L for the treatment of pediatric ...