FDA clinical trial guidances touch on Biden administration’s goals for advancing development of cancer treatments

RFK Jr. urges FDA staff to resist “agency capture” by special interests and resist “deep state”
Whistleblowers will be “honored”

As he addressed FDA employees, HHS Secretary Robert F. Kennedy Jr. described the Trump era as a “generational opportunity to make the regulatory agency live up to its foundational ideals” and emerge from the morass of what he described as the “deep state.”

Heated intraperitoneal chemotherapy associated with longer survival in ovarian cancer

Physicians at Tampa General Hospital and USF Health Morsani College of Medicine conducted a multicenter, retrospective cohort study and found that a highly specialized treatment—heated intraperitoneal chemotherapy delivered directly into the abdominal cavity, is associated with longer survival for women with metastatic epithelial ovarian cancer.

April 18, 2025

Vol.51 No.15

Clinical Roundup

Phase II trial analysis shows higher ORR in HR MDS when treated with bexmarilimab + azacitidine

Faron Pharmaceuticals Ltd. on April 14 announced positive topline results of the BEXMAB trial, which shows a high overall response rate among both frontline as well as relapsed/refractory high-risk myelodysplastic syndromes patients treated with a combination of bexmarilimab and azacitidine.

April 18, 2025

Vol.51 No.15

Clinical Roundup

Inherited cancer mutations may drive tumor growth, study shows

Most cancer genome studies have focused on mutations in the tumor itself and how such gene variants allow a tumor to grow unchecked. A study led by researchers at Washington University School of Medicine in St. Louis takes a deep dive into inherited cancer mutations measured in a healthy blood sample and reports how those mutations might take a toll on the body’s cells starting at birth, perhaps predisposing a person to develop cancers at various stages of life.

April 18, 2025

Vol.51 No.15

Drugs & Targets

FDA approves nivolumab + ipilimumab for unresectable or metastatic HCC

FDA on April 11 approved nivolumab (Opdivo) with ipilimumab (Yervoy) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma.

April 18, 2025

Vol.51 No.15

Drugs & Targets

FDA to phase out animal testing requirement for monoclonal antibodies, other drugs

FDA announced on April 10 its efforts to advance public health by replacing animal testing in the development of monoclonal antibody therapies and other drugs with more effective, human-relevant methods.

April 18, 2025

Vol.51 No.15

FDA clinical trial guidances touch on Biden administration’s goals for advancing development of cancer treatments

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RFK Jr. urges FDA staff to resist “agency capture” by special interests and resist “deep state”
Whistleblowers will be “honored”

Heated intraperitoneal chemotherapy associated with longer survival in ovarian cancer

Phase II trial analysis shows higher ORR in HR MDS when treated with bexmarilimab + azacitidine

Inherited cancer mutations may drive tumor growth, study shows

FDA approves nivolumab + ipilimumab for unresectable or metastatic HCC

FDA to phase out animal testing requirement for monoclonal antibodies, other drugs

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FDA clinical trial guidances touch on Biden administration’s goals for advancing development of cancer treatments

YOU MAY BE INTERESTED IN

RFK Jr. urges FDA staff to resist “agency capture” by special interests and resist “deep state”Whistleblowers will be “honored”

Heated intraperitoneal chemotherapy associated with longer survival in ovarian cancer

Phase II trial analysis shows higher ORR in HR MDS when treated with bexmarilimab + azacitidine

Inherited cancer mutations may drive tumor growth, study shows

FDA approves nivolumab + ipilimumab for unresectable or metastatic HCC

FDA to phase out animal testing requirement for monoclonal antibodies, other drugs

RFK Jr. urges FDA staff to resist “agency capture” by special interests and resist “deep state”
Whistleblowers will be “honored”