Oncologist biotech entrepreneur George Tidmarsh joins FDA as CDER director His appointment came out of “proximity” to Makary and Bhattacharya

With CDC in free fall, RFK Jr. faces bipartisan rebuke at Senate hearing
Kennedy calls CDC “the most corrupt agency at HHS and maybe the government.”

A Senate hearing that the administration hoped would be a routine check-in on the president’s 2026 MAHA-driven healthcare agenda erupted into a political firestorm as senators jumped at their first opportunity to confront HHS Secretary Robert F. Kennedy Jr. over the chaos engulfing the Centers for Disease Control and Prevention.

September 05, 2025

Vol.51 No.32

By Claire Marie Porter

Cancer Policy

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

Oncologist biotech entrepreneur George Tidmarsh joins FDA as CDER director

His appointment came out of “proximity” to Makary and Bhattacharya

YOU MAY BE INTERESTED IN

With CDC in free fall, RFK Jr. faces bipartisan rebuke at Senate hearing
Kennedy calls CDC “the most corrupt agency at HHS and maybe the government.”

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

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Oncologist biotech entrepreneur George Tidmarsh joins FDA as CDER director

His appointment came out of “proximity” to Makary and Bhattacharya

YOU MAY BE INTERESTED IN

With CDC in free fall, RFK Jr. faces bipartisan rebuke at Senate hearingKennedy calls CDC “the most corrupt agency at HHS and maybe the government.”

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

Never miss an issue!

Login

With CDC in free fall, RFK Jr. faces bipartisan rebuke at Senate hearing
Kennedy calls CDC “the most corrupt agency at HHS and maybe the government.”