FDA Investigating Risk of Secondary Cancers in Patients Administered CAR T-Cell Therapy
November 29th 2023The FDA will investigate all currently approved CAR T-cell treatments, as well as BCMA-directed and CD19-directed genetically modified autologous CAR T-cell therapies, for the risk of secondary T-cell malignancies.
Follicular Lymphoma Drug Co-Developed by AbbVie and Genmab Gets FDA Breakthrough Designation
November 27th 2023AbbVie and Genmab will share commercial responsibilities in the United States and Japan for epcoritamab-bysp (Epkinly), whereas AbbVie will be responsible for further global commercialization.
FDA Approves Truqap Plus Faslodex for Advanced HR-Positive Breast Cancer
November 17th 2023Capivasertib (Truqap) plus fulvestrant (Faslodex) is a first-of-its-kind combination for HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1 or PTEN biomarker alterations.
FDA Approves CorMedix Inc’s Treatment for Bloodstream Infections in Patients Receiving Dialysis
November 15th 2023Defencath is indicated for the prevention and treatment of catheter-related bloodstream infections in adults with kidney failure administered chronic hemodialysis via a central venous catheter.