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

Kennedy won Senate confirmation to his job, in part, by promising not to change the nation’s vaccine schedule. Since taking ...

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

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

The plans amount to an extraordinary flex of Robert F. Kennedy Jr.’s power as health secretary to make decisions ordinarily ...

On the FDA’s docket this month are two expansion bids, one for GSK’s asthma drug Nucala into COPD and another for Merck’s ...

Proposed changes to the vaccine approval system deserve the same scrutiny. Press reports indicate that new vaccines will be ...

As a doctor and retired Republican congressman, I urge our leaders to double down on life-saving preventive medicine.

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

The U.S. FDA is planning to require all new vaccines to undergo placebo-controlled trials before approval. Read more here.

The FDA has rehired at least some workers tasked with releasing public records generated by the agency's regulatory ...

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