Nicole Verdun, MD, super office director of the FDA’s Office of Therapeutic Products (OTP) and her deputy Rachael Anatol, PhD ...

The reported dismissal of high-ranking CBER officials Nicole Verdun and Rachael Anatol resurfaced lingering concerns about ...

Good morning! Today, we get deeper into the ousting of Nicole Verdun at the FDA, see promise from Vertex’s cell therapy for ...

The ouster of the FDA's chief regulator of cell and gene therapies came immediately after a disagreement with her boss over a ...

Robert F. Kennedy Jr. testified in front of largely combative congresspeople on vaccine policy, his MAHA report and more; the ...

In one of the first major tests of the new FDA leadership’s regulatory philosophy toward gene therapies for rare diseases, ...

This leadership vacuum follows another significant departure at the FDA. Peter Marks, former head of the Center for Biologics Evaluation and Research who worked closely with Verdun on establishing new ...

The Alliance for Regeneration Medicine (ARM), a trade group that represents more than 400 members companies across 25 ...

In the wake of Marks' exit, FDA Commissioner Marty Makary, M.D., named Vinay Prasad, M.D., to head up the CBER. In addition to that title, Prasad recently added the title of "chief medical and science ...

Capricor Therapeutics said on Tuesday the U.S. Food and Drug Administration will not convene its panel of outside experts before deciding on the company's cell therapy for a heart condition associated ...

The HHS said center directors deserve to be supported by managers aligned with aggressive goals “to expeditiously advance ...