July 24th 2025
The CRL was given because the FDA did not consider the phase 1/2 IGNYTE trial to be an adequate and well-controlled clinical investigation to provide substantial evidence to support approval
The Economics of Transthyretin-Mediated Amyloidosis: Balancing Equity and Access in Resource Allocation
Advancing Immunotherapy in Endometrial Cancer: A Managed Care Perspective on Personalized Care