Vinay Prasad, named to lead the FDA agency tasked with regulating vaccines and gene therapy, has made controversial comments ...

Novavax said on Thursday discussions with the U.S. health regulator on its COVID-19 shot are ongoing and a pathway to ...

The independent experts will meet on May 22 to discuss updates to the COVID-19 vaccine for the upcoming season.

In the wake of mass restructuring efforts across the Department of Health and Human Services, the FDA has missed yet another ...

A new vaccine that combines flu and COVID-19 protection in one shot shows promising results, but the U.S. Food and Drug ...

Dr. Vinay Prasad was an outspoken critic of the FDA’s response to the pandemic, including the former vaccine chief, Dr. Peter ...

In his new role with the FDA, Dr. Vinay Prasad will oversee the regulation of costly drugs, including vaccines, gene ...

The U.S. Food and Drug Administration said on Wednesday it will hold a meeting of experts on May 22 to discuss COVID-19 ...

The Food and Drug Administration announced Tuesday it has picked a new head of its center charged with vaccine approvals and other biologics products: Dr. Vinay Prasad, a vocal critic of the agency's ...

Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...

Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.

Senior leaders at the FDA began pushing Moderna and Pfizer to file for full, formal approval of their COVID vaccines for ...