ODAC reviews two longest-running accelerated approvals as FDA weighs using its new authority

The departure (and return) of Vinay Prasad

At the end of July, after just a few months as director of the Center for Biologics Evaluation and Research, Vinay Prasad resigned.

September 05, 2025

Vol.51 No.32

By Claire Marie Porter

Cancer Policy

Trump administration wants to rebuild stockpile of APIs to address drug shortages

To fight drug shortages that have dogged all of medicine—including oncology—for decades, the Trump administration is returning to a policy it first enacted during the president’s first term.

FDA will speed up public release of Complete Response Letters

FDA is shortening its timeline for publicizing Complete Response Letters, pledging to make them available to the public “promptly” after sponsors receive notice.

FDA approves expanded indication for Avtozma intravenous formulation in cytokine release syndrome

FDA has approved an expanded indication of the intravenous formulation of Avtozma (tocilizumab-anoh) to include the treatment of cytokine release syndrome in adults and pediatric patients aged two years and older.

September 05, 2025

Vol.51 No.32

Drugs & Targets

FDA grants breakthrough designation for Rina-S in advanced endometrial cancer

The FDA has granted Breakthrough Therapy Designation to rinatabart sesutecan (Rina-S), an investigational folate receptor alpha-directed, TOPO1-inhibitor antibody-drug conjugate, for the treatment of adult patients with recurrent or progressive endometrial cancer who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy.

September 05, 2025

Vol.51 No.32

Podcast

Gardiner Harris, acclaimed health care and pharma journalist, on his New York Times bestselling book

In his new book, “No More Tears: The Dark Secrets of Johnson & Johnson,” Gardiner Harris, who was previously the public health and pharmaceutical business reporter for The New York Times, talks about the history of the overuse of red blood cell growth factors in oncology.

August 27, 2025

ODAC reviews two longest-running accelerated approvals as FDA weighs using its new authority

YOU MAY BE INTERESTED IN

The departure (and return) of Vinay Prasad

Trump administration wants to rebuild stockpile of APIs to address drug shortages

FDA will speed up public release of Complete Response Letters

FDA approves expanded indication for Avtozma intravenous formulation in cytokine release syndrome

FDA grants breakthrough designation for Rina-S in advanced endometrial cancer

Gardiner Harris, acclaimed health care and pharma journalist, on his New York Times bestselling book

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