Innovation in biotechnology, particularly within the realm of cell therapy, hinges significantly on the expertise of regulatory professionals. These experts are instrumental in navigating complex regulatory landscapes and ensuring that scientific advances transition into viable, market-ready
The landscape of cancer treatment is ever-evolving, with new therapies continually pushing the boundaries of what is possible. Kiromic BioPharma's latest advancement, Deltacel, an allogeneic gamma delta T-cell (GDT) therapy, is showing significant promise in the treatment of advanced non-small cell
The field of spinal muscular atrophy (SMA) treatment has been dynamically evolving, and the latest breakthrough stems from Scholar Rock's Phase 3 clinical trial of apitegromab. This experimental drug is designed to preserve muscle function, representing a potential new standard of care for SMA
In the rapidly evolving field of biopharmaceutical manufacturing, innovations in mycoplasma and sterility testing are becoming paramount for ensuring product safety and efficacy. Applied Biosystems™ MycoSEQ™ Plus system and the Applied Biosystems™ SteriSEQ™ Rapid Sterility Testing System, both
The controversy surrounding Cassava Sciences and its experimental Alzheimer's drug, simufilam, has garnered significant attention within the medical and research communities, as well as among regulatory bodies and patient advocacy groups. Allegations of data manipulation and scientific misconduct
Biopharmaceutical companies face numerous challenges in the quest to develop and commercialize effective oncology drugs. The intricate journey from Phase 1 trials to market approval often sees only a small fraction of drugs succeeding, and even when they do, understanding how new drug approvals
