November 24, 2025

FDA Approves Pembrolizumab With Enfortumab Vedotin-ejfv for Muscle-Invasive Bladder Cancer

The FDA has approved pembrolizumab (Keytruda) or the subcutaneous formulation pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) in combination with enfortumab vedotin-ejfv (Padcev) for the...

The ASCO Post

November 12, 2025

Longtime FDA Innovator Appointed as Director of CDER

The Department of Health and Human Services and the FDA announced that Richard Pazdur, MD, has been appointed Director of the Center for Drug Evaluation and Research (CDER). Dr. Pazdur is a 26-year ve...

The ASCO Post

October 02, 2025

FDA Removes Vandetanib REMS Program

On September 25, the U.S. Food and Drug Administration (FDA) removed the Risk Evaluation and Mitigation Strategies (REMS) program for vandetanib, according to an announcement from the agency. 

The ASCO Post

August 22, 2025

Kinase Inhibitor Approved for Nonsquamous NSCLC With HER2 TKD–Activating Mutations

The agent was approved by the FDA today for adults with unresectable or metastatic nonsquamous NSCLC whose tumors have HER2 tyrosine kinase domain (TKD)–activating mutations, as detected by an FDA-app...

The ASCO Post

August 22, 2025

Protease Activator Approved by the FDA for Diffuse Midline Glioma

This represents the first FDA approval of a systemic therapy for H3 K27M–mutant diffuse midline glioma.

The ASCO Post

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