Makary: Level of evidence is an artificial and dogmatic construct

Kennedy: “We’re going to end the war at FDA against alternative medicine”

HHS Secretary Robert Kennedy Jr. asserted that under his leadership, FDA will “end the war” against alternative medicine.

FDA approves Ibtrozi oral treatment for advanced ROS1+ NSCLC

FDA has approved Ibtrozi (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer.

June 13, 2025

Vol.51 No.23

Cancer Policy

FDA booth stood empty at 2025 ASCO annual meeting

Booth 10025 became an unlikely crowd magnet at the exhibit hall at the annual meeting of the American Society of Clinical Oncology that ended earlier this week.

FDA rolls out agency-wide AI tool

FDA rolled out a generative artificial intelligence tool designed to help employees across the agency “work more efficiently.”

FDA approves Nubeqa for metastatic castration-sensitive prostate cancer

FDA approved the oral androgen receptor inhibitor Nubeqa (darolutamide) for the treatment of adult patients with metastatic castration-sensitive prostate cancer, which is also known as metastatic hormone-sensitive prostate cancer.

June 06, 2025

Vol.51 No.22

Drugs & Targets

FDA grants priority review for sevabertinib in HER2-mutant NSCLC

FDA accepted a new drug application and granted priority review designation for the investigational compound sevabertinib (BAY 2927088), an oral, small molecule, tyrosine kinase inhibitor, for the treatment of adult patients with advanced non-small cell lung cancer whose tumors have activating human epidermal growth factor receptors 2 (HER2) (ERBB2) mutations and who have received a prior systemic therapy.

May 30, 2025

Vol.51 No.21

Makary: Level of evidence is an artificial and dogmatic construct

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Kennedy: “We’re going to end the war at FDA against alternative medicine”

FDA approves Ibtrozi oral treatment for advanced ROS1+ NSCLC

FDA booth stood empty at 2025 ASCO annual meeting

FDA rolls out agency-wide AI tool

FDA approves Nubeqa for metastatic castration-sensitive prostate cancer

FDA grants priority review for sevabertinib in HER2-mutant NSCLC

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