Biopharma gains a seamless transition from drug discovery through drug product manufacturing SAN DIEGO, June 20, 2024 /PRNewswire/ — Abzena, the leading end-to-end integrated contract and development manufacturing organization (CDMO) for complex biologics and...
Freeline Therapeutics has announced a new name and brand to reflect its focus on developing a new generation of gene therapies and advancing the practice of genetic medicine. Moving forward, the brand will be called Spur Therapeutics. Building on compelling data for...
In a recent discussion, Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, and Janet Woodcock, former FDA deputy commissioner, highlighted the critical need for regulatory flexibility in developing rare disease therapies. They...
Graphical abstract. Credit: Cell Reports Medicine (2024). DOI: 10.1016/j.xcrm.2024.101552 Behind the scenes, as tumors progress and gain resistance to treatment, a protein called YB-1 quietly gives directions. Now, researchers at Oregon Health & Science University...
–Supplemental New Drug Application (sNDA) submission based on Phase 3 study of vibegron 75mg (GEMTESA) demonstrating statistically significant reductions in daily micturition and urgency episodes– –If approved, vibegron will be the first and only beta-3 agonist for...
