Vinay Prasad falls from grace at FDA upon flunking Trump political purity test MAHA leaders agree on one point: COVID was mishandled. Is that enough to run science-based agencies?

My introduction to, and lessons learned from, Rick Pazdur

Rick Pazdur, MD, the newly appointed director for the Center for Drug Evaluation and Research at the FDA, has been described as “greyhound thin” as a result of his dedication to cycling and lifting weights in the gym each day and, for a long time, a vegetarian diet. I first met him when he was the director of the Office of Oncology Drug Products (ODP) within CDER, in 2009.

November 21, 2025

Vol.51 No.43

By Mikkael A. Sekeres

Cancer Policy

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.

Darrow Zeidenstein named chief development officer at ACS

Darrow Zeidenstein was named chief development officer at the American Cancer Society and its advocacy affiliate the American Cancer Society Cancer Action Network. In this role, Zeidenstein will lead the organization’s development efforts, overseeing all aspects of resource generation, including corporate partnerships, philanthropy, planned giving, Discovery Shops, community-based fundraising, and revenue-generating field operations.

November 21, 2025

Vol.51 No.43

In Brief

Erik Sulman named interim executive director at Duke Cancer Institute

Erik Sulman will serve as the interim executive director of the Duke Cancer Institute, effective Jan. 5, 2026.

November 21, 2025

Vol.51 No.43

In Brief

Kate Klimczak appointed president of ACT for NIH, Richard Turman steps down

Kate KlimczakRichard TurmanRichard Turman announced that he will be stepping down from leadingAct for NIH, an NIH advocacy organization, and its affiliated education arm ACT for NIH Foundation, effective Jan. 1, 2026.

November 21, 2025

Vol.51 No.43

Drugs & Targets

FDA grants full approval of Imdelltra in ES-SCLC

FDA granted full approval to Imdelltra (tarlatamab-dlle) for the treatment of adult patients with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. The decision to convert Imdelltra’s prior accelerated approval to a full approval is based on data from the global phase III DeLLphi-304 study.

November 21, 2025

Vol.51 No.43

Vinay Prasad falls from grace at FDA upon flunking Trump political purity test

MAHA leaders agree on one point: COVID was mishandled. Is that enough to run science-based agencies?

YOU MAY BE INTERESTED IN

My introduction to, and lessons learned from, Rick Pazdur

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

Darrow Zeidenstein named chief development officer at ACS

Erik Sulman named interim executive director at Duke Cancer Institute

Kate Klimczak appointed president of ACT for NIH, Richard Turman steps down

FDA grants full approval of Imdelltra in ES-SCLC

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