December 18, 2025

FDA Approves Amivantamab and Hyaluronidase-lpuj for Subcutaneous Injection

The FDA approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) for subcutaneous injection for adult patients across all indications approved for the intravenous formulation of amivantamab (Ryb...

The ASCO Post

December 12, 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

December 09, 2025

Research Supports FDA Approval of Sevabertinib for HER2-Mutant Lung Cancer

The U.S. Food and Drug Administration (FDA) has approved sevabertinib, an oral targeted therapy, for adult patients with non-small-cell lung cancer (NSCLC) whose tumors harbor certain HER2 (ERBB2) mut...

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

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

July 29, 2025

FDA Grants Accelerated Approval to Linvoseltamab-gcpt for Relapsed or Refractory Multiple Myeloma

The agent was granted accelerated approval today for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an im...

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