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

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

The agency is changing the standard of evidence required for Covid-19 vaccine approval in the US, Dr. Vinay Prasad, the new ...

The U.S. Food and Drug Administration plans to require new clinical trials for approval of annual COVID-19 boosters for ...

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

(Reuters) -Advisers to the U.S. Food and Drug Administration will discuss whether to recommend COVID-19 vaccines for 2025-26 ...

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

The change marks a shift in the Food and Drug Administration’s policy on approving COVID-19 vaccines, which the new ...

Novavax originally showed its vaccine was safe and effective in a 30,000-person clinical trial. The FDA had been on track to ...

The rollout of updated Covid vaccines for healthy children and adults this fall is likely to be delayed after the FDA said it ...

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