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On November 18, 2025, the Food and Drug Administration approved epcoritamab-bysp (Epkinly, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy (epcoritamab-bysp was granted accelerated approval for this indication …

FDA approves epcoritamab-bysp for follicular lymphoma indications Read More »

FDA published Manual of Policies and Procedures (MAPP 5221.3), “Using Four-Part Harmony in OGD-Related Assessment Communications.” This external MAPP describes how Office of Generic Drugs (OGD) assessors can follow the principles of Four-Part Harmony to enhance the clarity of OGD-related communications sent to applicants during assessments across the product life cycle.

On November 13, 2025, the Food and Drug Administration approved Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics Co. Ltd.) as an interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc.). This is the first approval of a biosimilar for Perjeta.

The U.S. Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research has qualified glutamate dehydrogenase (GLDH) as a safety biomarker to detect possible drug-induced liver injury (DILI) in conjunction with alanine aminotransferase (ALT) and other standard liver injury markers in clinical trials, particularly in participants with elevated transaminases due to muscle injury. For example, patients …

FDA Qualifies Glutamate Dehydrogenase (GLDH) Biomarker to Enhance Liver Safety Monitoring in Clinical Trials Read More »

On November 13, 2025, the Food and Drug Administration approved ziftomenib (Komzifti, Kura Oncology, Inc.), a menin inhibitor, for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options.

Proposed removal of risk statements about cardiovascular diseases, breast cancer, and probable dementia from the Boxed Warnings, as well as other proposed safety-related labeling changes, to clarify the benefit/risk considerations for these drugs