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.

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

The FDA has already delayed the approval of Novavax’s updated Covid vaccine, requiring the company to carry out a new ...

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.

With the exception of his Treasury secretary, Trump’s Cabinet picks have confirmed earlier concerns. President Trump’s first 100 days have confirmed the initial concerns about some of his most ...

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

The potential change outlined in a statement would require all new vaccines to undergo placebo testing, sparking concerns among medical experts.

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

This coming Thursday was supposed to be the deadline for federal health systems to show the patient care decision-making ...