Denise Myshko

Articles by Denise Myshko

The FDA this week approved a few firsts: the first treatment for NASH and the first CAR-T cell therapy for CLL/SLL. Other approvals include Tevimbra for esophageal cancer; Livmarli for second liver disease indication; and Praluent for children with genetic form of high cholesterol. The FDA also issued a CRL for monthly MS drug. Additionally, Celltrion submitted an application for an interchangeable Xolair biosimilar.