Capricor Therapeutics said on Tuesday the U.S. Food and Drug Administration may not seek its outside experts' advice when ...

Vinay Prasad—the controversial head of vaccine regulation at the US Food and Drug Administration (FDA)—has been named FDA chief medical and scientific officer.1 Traditionally separate roles, his new ...

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

Curay, who stepped into the role as the agency’s top drug regulator in January, is departing in July, according to an email ...

When Americans imagine the future, it always has a lot to do with flying cars, robot housekeepers, and just about anything ...

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

Capricor stock drops as FDA cancels advisory meeting on Duchenne therapy; leadership changes and regulatory tensions fuel uncertainty.

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

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

The departure of Food and Drug Administration official Dr. Nicole Verdun, who was in charge of regulating gene therapies and cell therapies, is setting off a new round of worries for biotech investors ...

To no great surprise, the U.K.’s health technology assessment body has found that the benefits of the first two approved Alzheimer’s disease drugs are too small to justify the costs. Neither Kisunla ...

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