The FDA plans to “rapidly make available” rare disease drugs and make use of surrogate endpoints to get promising medicines ...

A new, highly transmissible COVID subvariant has been detected in California — heightening the risk of a summer wave as ...

Details aren't yet public but the plan is being overseen by the agency's new vaccine chief, Dr. Vinay ... Dr. Peter Marks, was forced to resign. Hoeg — along with Makary and Prasad — spent ...

The event will take place June 2-3 in Washington, D.C. Vinay Prasad, MD, MPH, the newly appointed Director of the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and ...

(PRNewsFoto/National Organization for Rare Disorders (NORD)) Vinay Prasad, MD, MPH, the newly appointed Director of the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and ...

FDA vaccine chief Dr. Vinay Prasad said in opening the meeting that the agency wants “to give people a little more time to digest” the new policy and is open to feedback from its experts ...

“We are asking for guidance to help the FDA decide what strain to select for COVID-19 vaccines going forward,” FDA vaccine chief Dr. Vinay Prasad said in comments opening the meeting. Prasad ...

WASHINGTON (AP) — Government advisers are meeting Thursday to decide if COVID-19 vaccines need updating to improve protection this fall and winter — even as a new Trump administration policy ...

Seven weeks into his job as FDA commissioner, Marty Makary, MD, MPH, held his own answering a barrage of sometimes acrimonious questions from Senators about agency staffing cuts, limits on COVID ...