The FDA vaccine approval road map proposes longer trials and stricter evidence to improve vaccine safety and effectiveness oversight.

A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that Covid-19 vaccination resulted in the deaths of 10 children.

Pregnant people have a higher risk of severe disease and death from COVID, so making it harder for them to get vaccinated ...

FDA vaccines chief says internal review found 10 child deaths linked to Covid shots • Shift would remake flu immunization strategy and tighten standards ...

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans.

FDA weighs black box warning for COVID-19 vaccines, signaling a major shift in safety labeling and regulatory approach for these shots.

The Food and Drug Administration (FDA) is set to implement stricter vaccine approval guidelines after a memo claimed at least ...

The FDA is reportedly considering the addition of high-level warning labels to COVID vaccines, a move that some experts say ...

Food and Drug Administration officials have opened a safety review of two injectable drugs used to protect babies and ...

The FDA plans to impose stricter vaccine approval rules, prompting warnings from Georgia doctors who fear the policy could ...

Shares of several major vaccine makers lost ground Monday following a report U.S. vaccine approval rules could become ...