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

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

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

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. 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 ...

“Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to ...

Moderna’s study, involving 8,000 adults 50 and older, showed the new combo shot generated an immune response against COVID and most strains of flu compared to existing stand-alone shots.

Some 20 travel staff at the FDA, who made arrangements for the regulator’s inspectors, will be getting their jobs back, as ...