FDA Alert
FDA Alert
02/20/2026
Ashton L. Stahl
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...
02/20/2026
FDA Alert
FDA Alert
02/12/2026
Ashton L. Stahl
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...
02/12/2026
FDA Alert
FDA Alert
02/05/2026
Anthony Calabro, MA
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...
02/05/2026
FDA Alert
FDA Alert
12/15/2025
Kate Young
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,...
12/15/2025
FDA Alert
FDA Alert
08/20/2025
Kate Young
The FDA approved Zongertinib for adults with unresectable or metastatic non-squamous NSCLC with HER2 (ERBB2) TKD activating mutations following prior systemic therapy.
08/20/2025
FDA Alert
FDA Alert
07/21/2025
Kate Young
The FDA announced on June 12 that it has approved pembrolizumab for adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1.
07/21/2025
FDA Alert
FDA Alert
06/20/2025
Miranda Manier, BA
The FDA has approved mitomycin intravesical solution for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
06/20/2025
FDA Alert
FDA Alert
06/04/2025
Kate Young
The FDA announced the approval of darolutamide for treating metastatic castration-sensitive prostate cancer. This review was conducted under Project Orbis, which allows for concurrent submission and review...
06/04/2025
FDA ALERT
FDA ALERT
09/13/2024
Jessica Ganga
In June, following a placebo-controlled trial, the FDA approved pembrolizumab with chemotherapy to treat patients with primary advanced or recurrent endometrial carcinoma.
09/13/2024
FDA Alert
FDA Alert
04/22/2024

Anthony Calabro, MA

Anthony Calabro, MA
The FDA previously approved lisocabtagene maraleucel as a second-line treatment option for adult patients with large B-cell lymphoma in June 2022.
04/22/2024