February 26, 2026

Advanced Nonsquamous NSCLC: FDA Grants Accelerated Approval to Zongertinib

The FDA granted accelerated approval to zongertinib (Hernexeos), a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic nonsquamous NSCLC whose tumors have HER2 tyro...

The ASCO Post

February 24, 2026

FDA Approves Pembrolizumab With Paclitaxel for Platinum-Resistant Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma

On February 10, the U.S. Food and Drug Administration (FDA) approved the PD-1 inhibitor pembrolizumab (Keytruda) as well as pembrolizumab and the recombinant human enzyme,berahyaluronidase alfa-pmph (...

The ASCO Post

February 23, 2026

FDA Releases Draft Guidance for Use of MRD and CR as Primary Endpoints in Multiple Myeloma Trials

On January 20, 2026, the U.S. Food and Drug Administration (FDA) released a draft guidance for industry regarding the use of minimal residual disease and complete response as primary endpoints in clin...

The ASCO Post

February 06, 2026

FDA Provides Safety Labeling Update for Capecitabine and Fluorouracil on Risks Associated With DPD Deficiency

The FDA has provided communication to increase awareness of recent updates to the product labeling of capecitabine (Xeloda) and fluorouracil—indicated for colorectal, breast, gastric/esophageal/gastro...

The ASCO Post

January 21, 2026

Regulatory Agencies Establish Principles of Good AI Use in Drug Development

The U.S. Food and Drug Administration's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research have collaborated with the European Medicines Agency to develop a set o...

The ASCO Post

January 12, 2026

FDA Increases Flexibility on Requirements for Cell and Gene Therapies

The FDA is sharing information about the agency’s flexible approach to overseeing chemistry, manufacturing, and control requirements for cell and gene therapies, which aims to expedite product develop...

The ASCO Post

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