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

Details of the new rules for COVID-19 vaccine approvals were also outlined in an article published by The New England Journal ...

No, this is not true. Vaccines undergo rigorous safety testing and are continuously monitored for adverse events.

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

The agency will require manufacturers to conduct randomized, controlled trials to secure approval for healthy Americans.

Federal officials unveiled a rigorous regulatory approach to future COVID vaccines that could make it harder for many people ...

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

The US Food and Drug Administration has fully approved a new COVID vaccine option specifically targeting high-risk individuals, including seniors. The protein-based Nuvaxovid vaccine, produced by ...

The most commonly reported adverse events with the AZD1222 COVID-19 vaccine are headache and fatigue, a large-scale active ...

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

There is no association between the COVID-19 vaccine and miscarriage, a new Obstetrics and Gynecology study confirms.

U.S. regulators will no longer approve COVID booster shots for healthy adults and children without new studies, adding a ...