FDA clears IND application for LTZ-301

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.”

TIL + pembro regimen achieves 24% response rate in solid epithelial tumors, marking a step forward in immunotherapy research

Immunotherapy has changed the course of blood cancers and melanomas, but is stubbornly ineffective for the treatment of most epithelial solid cancers—the cancers that kill about 90% of the more than 600,000 Americans who die of cancer each year.

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

Cancer Policy

Federal judge nixes FDA’s LDT rule, says agency exceeded its authority

A federal judge ruled that the FDA lacks the statutory authority to regulate laboratory developed tests, finding squarely in favor of plaintiffs in the consolidated lawsuits brought by American Clinical Laboratories Association, Association for Molecular Pathology, and others. ASCP submitted an amicus brief supporting the plaintiffs.

April 11, 2025

Vol.51 No.14

Clinical Roundup

MSK and City of Hope researchers develop test using machine learning to help predict immunotherapy response in lymphoma

Researchers with Memorial Sloan Kettering and City of Hope have created a tool that uses machine learning to assess a non-Hodgkin lymphoma patient’s likely response to chimeric antigen receptor T-cell therapy before starting the treatment, according to study results published on April 1 in Nature Medicine.

April 11, 2025

Vol.51 No.14

FDA clears IND application for LTZ-301

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”

TIL + pembro regimen achieves 24% response rate in solid epithelial tumors, marking a step forward in immunotherapy research

FDA approves nivolumab + ipilimumab for unresectable or metastatic HCC

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

Federal judge nixes FDA’s LDT rule, says agency exceeded its authority

MSK and City of Hope researchers develop test using machine learning to help predict immunotherapy response in lymphoma

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FDA clears IND application for LTZ-301

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”

TIL + pembro regimen achieves 24% response rate in solid epithelial tumors, marking a step forward in immunotherapy research

FDA approves nivolumab + ipilimumab for unresectable or metastatic HCC

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

Federal judge nixes FDA’s LDT rule, says agency exceeded its authority

MSK and City of Hope researchers develop test using machine learning to help predict immunotherapy response in lymphoma

Never miss an issue!

Login

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