Accelerated Approval Not the Finish Line, Says FDA Commissioner
Drugmakers will no longer be able to slow-walk their accelerated approvals to full regulatory approval, said FDA Commissioner Robert Califf, MD, during the J.P. Morgan Healthcare Conference on Tuesday, while also fielding questions on gene therapies and the modernization of clinical trials, among other topics. Accelerated Approval When asked about the kind of data needed […]
Year in Review: Multiple Myeloma
Developments in multiple myeloma over the past year were marked by the approvals of a first-in-class drug for relapsed or refractory disease and a second chimeric antigen receptor (CAR) T-cell therapy, as well as some encouraging news and disappointments on the research front. New Approvals Last month, the FDA granted accelerated approval to teclistamab (Tecvayli) […]