Bertagnolli raises paylines, creates Clinical Trials Innovation Unit, and announces National Cancer Plan

Anthony Letai pledges to ensure stability for extramural and intramural cancer science

Stepping into the NCI director’s job at the end of a nerve-racking year, Anthony Letai wants you to know that the federal government is not going out of the business of cancer research.

Pazdur leaves FDA after 25-year career that shaped the agency’s oncology regulations
BIO calls for the end of “constant turmoil,” urges the administration to “right the ship”

After three weeks of brutal combat, Richard Pazdur decided that he has had enough.

Vinay Prasad to CBER employees: “It is not wise for FDA to further pollute the scientific literature with papers we cannot defend”

Vinay Prasad, FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, has instructed his staff to check with him before continuing to work on ongoing submissions to journals or beginning new contract-funded projects to “ensure that we are not engaging in sunk cost fallacy, not publishing obviously erroneous work, and not being distracted from our core mission.”

FDA releases draft guidance on reducing testing on non-human primates for monoclonal antibodies

FDA issued a draft guidance on Dec. 2, outlining specific product types for which the FDA believes six-month non-human primate toxicity testing can be eliminated or reduced.

Andres Álvarez-Pinzón, Ronald Chen, Vered Stearns, Alexandra Thomas, Trisha Wise-Drapernamed to NRG Oncology leadership

NRG Oncology, NCI, and National Clinical Trials Network recently announced changes in leadership across multiple committees.

December 05, 2025

Vol.51 No.44

Drugs & Targets

FDA approves Keytruda and Keytruda Qlex + Padcev as perioperative treatment cisplatin-ineligible bladder cancer

FDA approved Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Padcev (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy. These approvals represent the first PD-1 inhibitor plus ADC regimens for this patient population.

December 05, 2025

Vol.51 No.44

Bertagnolli raises paylines, creates Clinical Trials Innovation Unit, and announces National Cancer Plan

YOU MAY BE INTERESTED IN

Anthony Letai pledges to ensure stability for extramural and intramural cancer science

Pazdur leaves FDA after 25-year career that shaped the agency’s oncology regulations
BIO calls for the end of “constant turmoil,” urges the administration to “right the ship”

Vinay Prasad to CBER employees: “It is not wise for FDA to further pollute the scientific literature with papers we cannot defend”

FDA releases draft guidance on reducing testing on non-human primates for monoclonal antibodies

Andres Álvarez-Pinzón, Ronald Chen, Vered Stearns, Alexandra Thomas, Trisha Wise-Drapernamed to NRG Oncology leadership

FDA approves Keytruda and Keytruda Qlex + Padcev as perioperative treatment cisplatin-ineligible bladder cancer

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Bertagnolli raises paylines, creates Clinical Trials Innovation Unit, and announces National Cancer Plan

YOU MAY BE INTERESTED IN

Anthony Letai pledges to ensure stability for extramural and intramural cancer science

Pazdur leaves FDA after 25-year career that shaped the agency’s oncology regulationsBIO calls for the end of “constant turmoil,” urges the administration to “right the ship”

Vinay Prasad to CBER employees: “It is not wise for FDA to further pollute the scientific literature with papers we cannot defend”

FDA releases draft guidance on reducing testing on non-human primates for monoclonal antibodies

Andres Álvarez-Pinzón, Ronald Chen, Vered Stearns, Alexandra Thomas, Trisha Wise-Drapernamed to NRG Oncology leadership

FDA approves Keytruda and Keytruda Qlex + Padcev as perioperative treatment cisplatin-ineligible bladder cancer

Never miss an issue!

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Pazdur leaves FDA after 25-year career that shaped the agency’s oncology regulations
BIO calls for the end of “constant turmoil,” urges the administration to “right the ship”