FDA grants Breakthrough Therapy Designation to epcoritamab-bysp

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.

Makary: Level of evidence is an artificial and dogmatic construct

Mehmet Oz, Robert F. Kennedy Jr., Marty Makary, Jayanta Bhattacharya, and Vinayak Prasad at an FDA Roundtable on Cell and Gene Therapy, June 5.Speaking at an FDA Roundtable on Cell and Gene Therapy, FDA Commissioner Marty Makary questioned the construct of “levels of evidence” as artificial and dogmatic, saying that n-of-1 “stories” can drive regulatory decisions.

June 06, 2025

Vol.51 No.22

By Jacquelyn Cobb