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

The FDA intends to place a black box label—its most serious warning—on COVID-19 vaccines, according to reporting by CNN. It ...

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

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

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.

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.

The US Food and Drug Administration’s new vaccine approval philosophy upends established regulatory practices and could put the health and safety of Americans at risk, according to an article written ...

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