Moderna Inc. shares declined after the company’s first-quarter vaccine sales missed estimates and it disclosed a delay in the ...

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

The US Food and Drug Administration will require all new vaccines to undergo placebo-controlled trials before approval — a ...

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

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

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

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

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

FDA vaccine oversight is shifting, with increased scrutiny and mixed messaging sparking concerns among health experts.

The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve COVID-19 vaccines for next winter, citing a lack of data on booster shots.

From STAT’s Jason Mast: Moderna said this morning in its earnings report it planned to cut costs by around $1.5 billion by ...

Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” ...