FDA grants priority review to HER2-directed therapy as first-line treatment of HER2-positive metastatic breast cancer

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.

December 05, 2025

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FDA releases draft guidance on reducing testing on non-human primates for monoclonal antibodies

FDA issued a draft guidance on Dec. 2, outlining specific product types for which the FDA believes six-month non-human primate toxicity testing can be eliminated or reduced.

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

Drugs & Targets

FDA grants 501(k) clearance for Vanquish System for prostate tissue ablation in intermediate risk prostate cancer

FDA has granted 510(k) clearance for use of the Vanquish System for prostate tissue ablation. FDA clearance was supported by positive 12-month follow-up data on the first 110 patients enrolled in the company’s ongoing VAPOR 2 clinical study.

December 05, 2025

Vol.51 No.44

Drugs & Targets

FDA approves durvalumab + FLOT for resectable gastric or gastroesophageal junction adenocarcinoma

FDA approved durvalumab with fluorouracil, leucovorin, oxaliplatin, and docetaxel chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent durvalumab, for adults with resectable gastric or gastroesophageal junction adenocarcinoma.

December 05, 2025

Vol.51 No.44

FDA grants priority review to HER2-directed therapy as first-line treatment of HER2-positive metastatic breast cancer

YOU MAY BE INTERESTED IN

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

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

FDA grants 501(k) clearance for Vanquish System for prostate tissue ablation in intermediate risk prostate cancer

FDA approves durvalumab + FLOT for resectable gastric or gastroesophageal junction adenocarcinoma

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FDA grants priority review to HER2-directed therapy as first-line treatment of HER2-positive metastatic breast cancer

YOU MAY BE INTERESTED IN

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

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

FDA grants 501(k) clearance for Vanquish System for prostate tissue ablation in intermediate risk prostate cancer

FDA approves durvalumab + FLOT for resectable gastric or gastroesophageal junction adenocarcinoma

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”