A combination shot for flu and COVID-19 using messenger RNA generated antibodies in a study, but U.S. government regulators ...

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

Officials in sixteen states and the District of Columbia sued in response, leading to Tuesday’s order from U.S. District ...

The Trump administration's effort to impose new requirements on Novavax's COVID-19 vaccine is sowing uncertainty about other ...

The advisory committee meeting is an important step in the process of readying boosters for the fall and winter season, but ...

Yes, according to leading vaccine physician Paul Offit, who denounced the new placebo-controlled trial requirements for ...

The FDA is expected to unpause the only protein-based COVID-19 vaccine's transition from emergency approval to full approval.

Dr. Vinay Prasad, a prominent critic of the pharmaceutical industry and the Food and Drug Administration, has been named to ...

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

Several current and former FDA employees who spoke to Inside Medicine on the condition of anonymity have come to see the ...

The FDA was on track to grant Novavax full approval by its April 1 target date, according to two people with direct knowledge of the situation who spoke on condition of anonymity to discuss ...

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