On March 25, the FDA has approved relacorilant (Lifyorli), in combination with nab-paclitaxel for adults with platinum-resistant ovarian and related gynecologic cancers who have received prior systemic...
The FDA has granted full approval for the use of brexucabtagene autoleucel in adults with relapsed or refractory mantle cell lymphoma, based on confirmatory ZUMA-2 data.
The FDA has approved Opdivo (nivolumab) in combination with doxorubicin, vinblastine, and dacarbazine for adults and pediatric patients aged 12 years and older with previously untreated stage III or IV...
Based on findings from the phase 3 MajesTEC-3 trial, the FDA announced the approval of teclistamab (Tecvayli) plus daratumumab hyaluronidase-fihj for adults with relapsed or refractory multiple myeloma who...
The FDA has granted traditional approval for the use of encorafenib (Braftovi) in combination with cetuximab and fluorouracil-based chemotherapy for treatment-naïve adults with BRAF V600E–mutant metastatic...
The FDA has approved a chemotherapy-free combination of acalabrutinib and venetoclax for adults with previously untreated CLL or SLL, based on a randomized phase 3 trial demonstrating a progression-free...
The FDA has authorized a first-of-its-kind therapeutic device that delivers tumor-treating fields for adults with locally advanced pancreatic cancer. The approval offers a new non-invasive option to extend...
The FDA approval expands frontline treatment options for adults with newly diagnosed multiple myeloma who are not candidates for autologous stem cell transplant, based on randomized trial data showing...
An open-label, randomized trial found that daratumumab and hyaluronidase-fihj administered subcutaneously improved the risk of disease progression or death in patients with multiple myeloma. As a result,...
The FDA approved Zongertinib for adults with unresectable or metastatic non-squamous NSCLC with HER2 (ERBB2) TKD activating mutations following prior systemic therapy.
