The agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, ...

"The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at ...

In an editorial article published in the New England Journal of Medicine, Dr. Vinay Prasad, the newly appointed head of the ...

The requirement for placebo-controlled trials isn’t expected to affect the rollout this fall for older adults and other groups at high risk for severe illness.

The FDA announced it will limit full approval of future COVID-19 booster vaccines to individuals older than 65 and those at high risk for severe disease, marking a shift from the agency’s previous one ...

Federal health officials will no longer routinely approve annual COVID-19 shots for younger adults and children who are ...

Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many ...

FDA FLAGS SEVERE ITCH — Patients who stop using the oral allergy medicines cetirizine (Zyrtec) or levocetirizine (Xyzal) may ...

Previously granted Emergency Use Authorization, Nuvaxovid is now available for individuals over 12 years of age.

The FDA also gave full approval to the Novavax COVID vaccine (Nuvaxovid) using this approach, approving it for those ages 65 ...

The agency will narrow its approval for updated coronavirus vaccines, marking a significant shift in the agency’s approach to ...

In an era that FDA Commissioner Marty Makary, MD, MPH, calls an "epidemic of distrust" toward health institutions, previously ...