FDA approves Cologuard Plus Test for non-invasive CRC screening

Makary, Prasad describe FDA’s new “plausible mechanism pathway” to get bespoke therapies to market sans RCT

FDA Commissioner Marty Makary and Vinay Prasad, FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, jointly published a letter in The New England Journal of Medicine spelling out the rationale for FDA’s new “plausible mechanism pathway,” aimed at getting bespoke therapies to market without the need for a randomized controlled trial.

November 21, 2025

By Jacquelyn Cobb

Podcast

Ellen Sigal and Karen Knudsen “gush” about new CDER Director Richard Pazdur and his late wife, Mary

Last week, Richard Pazdur was named to the position of director of FDA’s Center for Drug Evaluation and Research. Much has been written about how Pazdur, with nearly a three-decade long career at the agency, represents a stabilizing choice for FDA as it faces inner and outer turmoil.

November 19, 2025

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.

November 14, 2025

Vol.51 No.42

By C. Ola Landgren

FDA approves Cologuard Plus Test for non-invasive CRC screening

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Makary, Prasad describe FDA’s new “plausible mechanism pathway” to get bespoke therapies to market sans RCT

Ellen Sigal and Karen Knudsen “gush” about new CDER Director Richard Pazdur and his late wife, Mary

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

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FDA approves Cologuard Plus Test for non-invasive CRC screening

YOU MAY BE INTERESTED IN

Makary, Prasad describe FDA’s new “plausible mechanism pathway” to get bespoke therapies to market sans RCT

Ellen Sigal and Karen Knudsen “gush” about new CDER Director Richard Pazdur and his late wife, Mary

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

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