ODAC nixes GSK’s Blenrep myeloma regimens, citing ocular toxicity, dosing, applicability to U.S. population

Rick Pazdur’s CDER appointment comes at exactly the right moment for FDA

Rick Pazdur’s appointment as director of the FDA’s Center for Drug Evaluation and Research (CDER) comes at exactly the right moment, both for the agency and for the patients it serves.

November 14, 2025

By Ellen V. Sigal

Clinical Trials & Tribulations

Smoldering multiple myeloma: Rethinking the waiting game

With the recent FDA approval of daratumumab for high-risk smoldering multiple myeloma, the moment is ripe to revisit the evolution of our understanding of smoldering multiple myeloma. This development not only underscores the growing recognition of early intervention but also invites a broader reflection on the biological insights and therapeutic strategies that have shaped—and continue to shape—this transitional disease state.

November 14, 2025

By C. Ola Landgren

Drugs & Targets

FDA approves Komzifti for r/r NPM1-mutated AML

FDA has granted full approval of Komzifti (ziftomenib) for adult patients with relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. Komzifti is the first and only once-daily, oral menin inhibitor approved for R/R NPM1-mutated AML, a devastating blood cancer with limited treatment options.

November 14, 2025

Podcast

Tidmarsh is out, Pazdur is in: FDA’s CDER under new leadership

Richard Pazdur, founding director of FDA’s Oncology Center of Excellence and long-time FDA visionary, has accepted the top job at FDA’s Center for Drug Evaluation and Research following George F. Tidmarsh’s dramatic ouster from the position.

November 12, 2025

Regulatory News

CDER Director Tidmarsh quits amid inspector general probe of his “personal conduct”
Cancer advocates express concern about comments that signal trouble for accelerated approval

George F. Tidmarsh has resigned from his job as director of the FDA Center for Drug Evaluation and Research in the aftermath of a lawsuit by a former associate and a probe into what an HHS spokesperson described as “serious concerns about his personal conduct.”

November 07, 2025

Vol.51 No.41

By Claire Marie Porter and Paul Goldberg