FDA Commissioner Dr. Marty Makary and vaccine chief Dr. Vinay Prasad set stricter approval standards for booster shots ...

The FDA may limit annual COVID-19 boosters to high-risk groups unless clinical trials prove benefits for healthy adults under ...

The FDA announced it will limit access to Covid-19 vaccines going forward to people 65 and older and others at high risk of serious illness ...

The Food and Drug Administration will no longer approve COVID-19 vaccines for healthy people under 65 without rigorous trials ...

Regulators will require more data showing the shots are safe and effective for healthy adults and children, by requiring ...

FDA Commissioner Marty Makary announced Thursday that the agency will soon provide clear guidelines to vaccine manufacturers ...

FDA Commissioner Marty Makary and top U.S. vaccines regulator ... Investors reacted favorably to the news, and shares of COVID vaccine makers rose. In late morning trading, shares of Moderna ...

Health agencies working under Robert F. Kennedy Jr. are making changes to the nation's decades-old system for approving and ...

The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.

US regulators will no longer approve Covid booster shots for healthy adults and children without new studies, adding a costly ...

New FDA framework on changes coronavirus vaccine approval will be released “in the coming days,” FDA Commissioner Marty ...

The head of the Food and Drug Administration said the agency will soon unveil a new framework detailing what companies must ...