FDA issues CRL for RP1+ nivolumab BLA for treatment of advanced melanoma

Conversation with The Cancer Letter Regulatory News

Richard Pazdur, a respected insider with a plan to reengineer FDA, steps in as CDER director

Richard Pazdur, FDA’s top oncologist who last week received a battlefield promotion to the role of director of the FDA Center for Drug Evaluation and Research, is described as a stabilizing figure respected by major patient groups, oncology professional societies, and the industry.

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

Vol.51 No.42

By Ellen V. Sigal

Clinical Regulatory News

FDA to remove black box warnings on hormone therapy for menopause
Trump-era “gold standard science” is not to be confused with gold standard of scientific evidence

Top FDA officials said the agency is in the process of removing the black box safety warnings from all forms of menopausal hormone therapy, including creams, pills, and other treatments prescribed to ease the symptoms of menopause and perimenopause.

November 14, 2025

Vol.51 No.42

By Claire Marie Porter

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.

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

Vol.51 No.42

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

FDA issues CRL for RP1+ nivolumab BLA for treatment of advanced melanoma

YOU MAY BE INTERESTED IN

Richard Pazdur, a respected insider with a plan to reengineer FDA, steps in as CDER director

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

FDA to remove black box warnings on hormone therapy for menopause
Trump-era “gold standard science” is not to be confused with gold standard of scientific evidence

Smoldering multiple myeloma: Rethinking the waiting game

FDA approves Komzifti for r/r NPM1-mutated AML

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

Renew today!

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FDA issues CRL for RP1+ nivolumab BLA for treatment of advanced melanoma

YOU MAY BE INTERESTED IN

Richard Pazdur, a respected insider with a plan to reengineer FDA, steps in as CDER director

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

FDA to remove black box warnings on hormone therapy for menopauseTrump-era “gold standard science” is not to be confused with gold standard of scientific evidence

Smoldering multiple myeloma: Rethinking the waiting game

FDA approves Komzifti for r/r NPM1-mutated AML

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

Never miss an issue!

Login

FDA to remove black box warnings on hormone therapy for menopause
Trump-era “gold standard science” is not to be confused with gold standard of scientific evidence