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.

The U.S. Food and Drug Administration (FDA) is considering adding the strongest safety warning available to COVID-19 vaccines ...

“FDA is doing a thorough investigation, across multiple age groups, of deaths potentially related to coronavirus vaccines,” said Andrew Nixon, spokesperson for the U.S. Department of Health and Human ...

The U.S. Food and Drug Administration plans to change how COVID vaccines and other shots are approved and administered. In a ...

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

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.

Pfizer's COVID-19 vaccine has become the first in the U.S. to receive full approval from the FDA for people ages 16 and up.

The agency’s decision is based on claims that the Covid vaccine was linked to the deaths of 10 children.

The FDA’s vaccine chief says the agency plans to tighten approval standards for COVID vaccines, citing concerns about potential risks for children. In a leaked memo, Dr. Vinay Prasad says a review of ...

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