FDA grants Rare Pediatric Disease designation for THIO in pediatric high-grade gliomas

Sotorasib + panitumumab offers better outcomes in colorectal cancer that no longer responds to treatment

A novel combination therapy offers better outcomes for patients with KRAS G12C metastatic colorectal cancer that have stopped responding to chemotherapy, according to a phase III clinical trial by researchers at City of Hope.

May 02, 2025

Vol.51 No.17

Regulatory News

Makary vows to speed up drug approvals and end FDA’s “cozy” relationship with industry
Commissioner promises to protect scientific integrity while bringing in “fresh” MAHA ideas

In his first sit-down interview since beginning his role as FDA commissioner 17 days earlier, Marty Makary, a former Johns Hopkins surgeon and the only Trump pick for HHS whose confirmation received Democratic support, said he would speed up approvals for rare-disease treatments by reducing reliance on animal testing and shifting towards organoids and computational models.

April 25, 2025

Vol.51 No.16

By Claire Marie Porter

Cancer Policy

ASCO seeks to engage new leaders of NIH, CMS, and FDA

The Association for Clinical Oncology has reached out to the new leaders of federal health agencies to ensure continued progress in cancer care, research, and patient access, the organization said.

FDA’s Richard Pazdur to receive the 2025 AACR Enduring Impact Award for transformative service to cancer science and medicine

The 2025 AACR Enduring Impact Award for Transformative Service to Cancer Science and Medicine will be presented to FDA’s Richard Pazdur during the AACR Annual Meeting 2025, to be held April 25-30 at the McCormick Place Convention Center in Chicago.

April 25, 2025

Vol.51 No.16

Drugs & Targets

FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinoma

FDA approved penpulimab-kcqx with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma. FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.

April 25, 2025

Vol.51 No.16

Drugs & Targets

FDA grants Breakthrough Therapy designation for B7-H3 CAR T-cell therapy for diffuse intrinsic pontine glioma

BrainChild Bio Inc. announced that its investigational B7-H3 targeting autologous CAR T-cell therapy has been granted Breakthrough Therapy designation by FDA for the treatment of diffuse intrinsic pontine glioma, an incurable pediatric brain tumor.

April 25, 2025

Vol.51 No.16

FDA grants Rare Pediatric Disease designation for THIO in pediatric high-grade gliomas

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Sotorasib + panitumumab offers better outcomes in colorectal cancer that no longer responds to treatment

Makary vows to speed up drug approvals and end FDA’s “cozy” relationship with industry
Commissioner promises to protect scientific integrity while bringing in “fresh” MAHA ideas

ASCO seeks to engage new leaders of NIH, CMS, and FDA

FDA’s Richard Pazdur to receive the 2025 AACR Enduring Impact Award for transformative service to cancer science and medicine

FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinoma

FDA grants Breakthrough Therapy designation for B7-H3 CAR T-cell therapy for diffuse intrinsic pontine glioma

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FDA grants Rare Pediatric Disease designation for THIO in pediatric high-grade gliomas

YOU MAY BE INTERESTED IN

Sotorasib + panitumumab offers better outcomes in colorectal cancer that no longer responds to treatment

Makary vows to speed up drug approvals and end FDA’s “cozy” relationship with industryCommissioner promises to protect scientific integrity while bringing in “fresh” MAHA ideas

ASCO seeks to engage new leaders of NIH, CMS, and FDA

FDA’s Richard Pazdur to receive the 2025 AACR Enduring Impact Award for transformative service to cancer science and medicine

FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinoma

FDA grants Breakthrough Therapy designation for B7-H3 CAR T-cell therapy for diffuse intrinsic pontine glioma

Never miss an issue!

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Makary vows to speed up drug approvals and end FDA’s “cozy” relationship with industry
Commissioner promises to protect scientific integrity while bringing in “fresh” MAHA ideas