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
06/21/2025
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.
06/21/2025
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
FDA Alert
FDA Alert
03/04/2024
Anthony Calabro, MA
The FDA approved irinotecan liposome with oxaliplatin, fluorouracil, and leucovorin as a first-line regimen for the management of patients with metastatic pancreatic adenocarcinoma.
03/04/2024
FDA ALERT
FDA ALERT
01/26/2024
Anthony Calabro, MA
The FDA approved pirtobrutinib for adults with either chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy.
01/26/2024
fda alert
fda alert
10/19/2023
Leigh Precopio
The FDA approved the use of quizartinib for certain patient populations with acute myeloid leukemia in July 2023.
10/19/2023