If the FDA deems Pfizer’s and Moderna’s updated vaccines “new” products, it’s extremely unlikely the doses would be ready for ...

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

The US Department of Health and Human Services said it will require that all new vaccines be tested in placebo-controlled ...

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

The US Department of Health and Human Services said Thursday that it aims to accomplish within four years a scientific feat ...

The new policy, revealed by the Department of Health and Human Services on Wednesday, would make vaccines “less available and ...

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

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

On a Thursday conference call with investors, Moderna CFO Jamey Mock outlined a roadmap for the mRNA specialist to lower its ...

According to the WSJ, the universal vaccine project is being pioneered by two recently appointed senior scientists in the NIH ...

Health Secretary Robert F. Kennedy Jr. on Thursday announced plans to require all new vaccines to be tested against placebos ...

The FDA chief has called into question whether the agency will approve and authorize the COVID-19 vaccine for winter. In ...