FDA Releases CRLs for Previous Drug and Biologic Product Applications
The FDA has published a collection of complete response letters that were seeking the approval of drugs or biologic products between 2020 and 2024.
Related Articles
Oncologists Highlight Key Takeaways and Abstracts From the 2025 ESMO GI Cancers Congress
Oncology experts recap their key takeaways from the 2025 ESMO Gastrointestinal Cancers Congress.
Dostarlimab Plus Chemo Prolongs Time to First, Second Subsequent Therapy Regardless of Age in Endometrial Cancer
After 3 years of follow-up, dostarlimab plus chemotherapy was effective and tolerable in patients aged 70 years or older with endometrial cancer.
IMPORTANT SAFETY INFORMATION
Clinical Outcomes with Epcoritamab in Relapsed/Refractory 3L+ DLBCL Review efficacy and safety data, including extended follow-up data from the EPCORE ® NHL-1 trial, which evaluated…
Most Patients With Advanced Melanoma Who Received Pre-Surgical Immunotherapy Remain Alive and Disease Free Four Years Later
Researchers found potential biomarkers that can highly predict which patients with stage III melanoma have better outcomes or are at high risk of recurrence.
Precision Medicine in Bladder Cancer: Exploring the Role of FGFR Biomarkers
Bladder Cancer Landscape
Lisaftoclax Wins Chinese Approval in Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
The NMPA has approved lisaftoclax in adult patients with relapsed/refractory CLL/SLL.
FDA Grants Orphan Drug Designation to ADRX-0405 for Gastric Cancer
ADRX-0405 has received orphan drug designation from the FDA for the treatment of patients with gastric cancer.
A Closer Look at Issues With the Expanding Role of Precision Medicine in Cancer Management
Maurie Markman, MD, raises concerns about public health priorities and resource allocation in light of the expanding role of precision medicine in cancer.
Glofitamab Plus Pirtobrutinib Yields High Activity, Tolerability in Covalent BTK Inhibitor–Exposed MCL
Results from the GoldiLox trial showed high complete and MRD-negative responses with glofitamab plus pirtobrutinib in covalent BTK inhibitor–exposed MCL.