The U.S. Food and Drug Administration (FDA) may not renew the Emergency Use Authorization for the Pfizer-BioNTech COVID-19 vaccine for children under the age of five, the company said. The possible ...

According to the FDA, an Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such ...

CAMBRIDGE, Mass. - Moderna announced Thursday that it has asked the U.S. Food and Drug Administration to expand the emergency approval of its COVID-19 vaccine to those aged 12 to 17. The company said ...

The US Food and Drug Administration on Thursday halted the emergency use authorization of Evusheld because it does not appear to protect against COVID-19 from viral variants currently circulating in ...

The Food and Drug Administration (FDA) is considering revoking the authorization of Pfizer’s COVID-19 vaccine for healthy children under 5 years old, the company confirmed Wednesday. The move would ...

Transitioning COVID-19 tests from emergency use authorization to the traditional pre-market pathway has long been a goal for the FDA. “Today’s authorization is the first at-home COVID-19 test granted ...