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

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

A blanket requirement for placebo-controlled trials threatens research ethics and vaccine access, it’s being argued.

Robert F. Kennedy Jr., who oversees the FDA, intends to set new regulatory standards vaccine manufacturers couldn’t possibly ...

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

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

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

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

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

Per the Post, which first reported the story, “‘All new vaccines will undergo safety testing in placebo-controlled trials ...

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

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