FDA accepts BLA for Priority Review of Opdivo + Yervoy in first-line NSCLC

Steven Libutti tells us about building a $900 million cancer hospital for Rutgers RWJBarnabas Health

Over the past seven years, as Steven K. Libutti was designing the 12-story, $900-plus million cancer hospital in New Brunswick, NJ, he often thought of the functionality of the building that inspired it: Building 10, the NIH Clinical Center.

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I did not find the process of being suddenly without employment as refreshing as one might think. It did, however, provide a forced opportunity to engage in self-reflection, to critically analyze the situation around cancer, and to face the complex set of problems that cancer, and society, present to us.

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By W. Kimryn Rathmell

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Makary vows to speed up drug approvals and end FDA’s “cozy” relationship with industry
Commissioner promises to protect scientific integrity while bringing in “fresh” MAHA ideas

In his first sit-down interview since beginning his role as FDA commissioner 17 days earlier, Marty Makary, a former Johns Hopkins surgeon and the only Trump pick for HHS whose confirmation received Democratic support, said he would speed up approvals for rare-disease treatments by reducing reliance on animal testing and shifting towards organoids and computational models.

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We are at a transformational period in oncology; the overall mortality from cancer is gradually declining in the United States.

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By Suresh S. Ramalingam and Adam Marcus

Advancing peritoneal oncology: Innovations in surgical strategies and research

Peritoneal metastases arise from gastrointestinal and gynecologic malignancies, leading to debilitating symptoms and poor prognoses. They remain one of the most challenging manifestations of advanced malignancies, often leading to significant morbidity and limited treatment options.

Regulation must keep up with scientific advances

The American Cancer Society’s recent report on the increasing incidence rates of colorectal cancer in young adults once again rang an alarm bell for adults over 45 to get checked, especially if they are having symptoms. But as an oncologist with more than 40 years of experience, I also believe that this should be a clarion call to scientists and researchers, and for regulators at the FDA.

April 25, 2025

Vol.51 No.16

By Richard M. Goldberg

FDA accepts BLA for Priority Review of Opdivo + Yervoy in first-line NSCLC

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Makary vows to speed up drug approvals and end FDA’s “cozy” relationship with industry
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FDA accepts BLA for Priority Review of Opdivo + Yervoy in first-line NSCLC

YOU MAY BE INTERESTED IN

Steven Libutti tells us about building a $900 million cancer hospital for Rutgers RWJBarnabas Health

In her own words: Rathmell reflects on her priorities and values—and encourages everyone to do the same

Makary vows to speed up drug approvals and end FDA’s “cozy” relationship with industryCommissioner promises to protect scientific integrity while bringing in “fresh” MAHA ideas

Ci4CC’s 23rd Cancer Center Summit to focus on accelerating oncology innovation through AI

Advancing peritoneal oncology: Innovations in surgical strategies and research

Regulation must keep up with scientific advances

Makary vows to speed up drug approvals and end FDA’s “cozy” relationship with industry
Commissioner promises to protect scientific integrity while bringing in “fresh” MAHA ideas