The U.S. Food and Drug Administration plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65, effectively limiting their availability this fall to ...

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

The FDA is tightening its regulatory policy around COVID vaccines with a new framework that raises the bar for approvals in ...

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 ...

COVID-19 shots for healthy younger adults and children will no longer be routinely approved under a major new policy shift ...

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 ...