June 30, 2025

FDA Approves Nivolumab With Ipilimumab for Unresectable or Metastatic MSI-H/dMMR Colorectal Cancer

The FDA approved the combination of a PD-1 inhibitor and a CTLA-4 inhibitor for patients with unresectable or metastatic microsatellite instability–high or mismatch repair–deficient colorectal cancer ...

The ASCO Post

June 27, 2025

FDA Approves Bevacizumab Biosimilar

Bevacizumab-nwgd is indicated for use in the treatment of certain kinds of colorectal, lung, brain, kidney, and cervical cancers.

The ASCO Post

June 27, 2025

FDA Approves At-Home Self-Collection Device for Cervical Cancer Screening

Teal Health announced the FDA's approval of the Teal Wand, an at-home vaginal sample self-collection device for cervical cancer screening in the United States.

The ASCO Post

June 19, 2025

FDA Approves CD19-Directed Antibody–Based Regimen for Follicular Lymphoma

The FDA has approved tafasitamab-cxix (Monjuvi), a CD19-directed cytolytic antibody, with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma.

The ASCO Post

August 29, 2023

FDA Approves Luspatercept-aamt as First-Line Treatment for Adult Patients With Lower-Risk MDS and Anemia Who May Require Transfusions

On August 28, the U.S. Food and Drug Administration (FDA) approved luspatercept-aamt (Reblozyl) to treat anemia in adult patients with very low– to intermediate-risk myelodysplastic syndromes (MDS) wh...

The ASCO Post

June 21, 2023

FDA Launches Pilot Program to Help Reduce Risks Associated With Using Laboratory Developed Tests to Identify Cancer Biomarkers

The U.S. Food and Drug Administration (FDA) announced a new voluntary pilot program to help physicians select safe and effective cancer treatments, with guidance on in vitro companion diagnostic tests...

The ASCO Post

November 17, 2023

FDA Approves Capivasertib With Fulvestrant for Breast Cancer

On November 16, 2023, the U.S. Food and Drug Administration (FDA) approved capivasertib (Truqap) with fulvestrant for adult patients with hormone receptor–positive, HER2-negative locally advanced or m...

The ASCO Post

August 05, 2024

FDA Grants Accelerated Approval to T-Cell Therapy for Unresectable or Metastatic Synovial Sarcoma

On August 2, the FDA granted accelerated approval to afamitresgene autoleucel (Tecelra), a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T-cell immunotherapy, for a...

The ASCO Post

August 28, 2024

FDA Approves Cancer Biomarker Test, Companion Diagnostic Indications

The FDA has approved the in vitro diagnostic TruSight Oncology Comprehensive test and its first two companion diagnostic indications. This targeted sequencing panel interrogates over 500 genes to prof...

The ASCO Post