At the recent CBER agency workshop on cell therapies and tissue-based products, a few surprising ideas discussed could have ...

The recommendations were made in a closed session with representatives from CBER, the CDC and Department of Defense.

The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...

Celia Witten, M.D., Ph.D., is no longer deputy director of the FDA’s Center for Biologics Evaluation and Research (CBER), joining the long list of health agency leaders who have departed since ...

from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) filing for deramiocel, an investigational cell therapy, as a treatment for patients diagnosed with ...

Today, the U.S. Food and Drug Administration (FDA) has accepted Genentech’s Supplemental Biologics License Application (sBLA ... Visit our Lupus Nephritis Information Center to learn about symptoms, ...

Cavazzoni was the head of the FDA’s Center for Drug Evaluation and Research (CDER), from 2020 until her departure in January. She was one of several top FDA officials who left the agency ahead ...

The FDA’s Center for Biologics Evaluation and Research (CBER) ran the meeting, which also had some encouraging presentations on early cell therapy trials. The workshop was held just days after ...