The agency’s high-level turnover and conflicting policy decisions on drug oversight have fueled concerns about the leadership of Dr. Marty Makary.

The agency claimed that 10 children’s deaths were linked to the shots, although it did not release evidence to support the assertions.

The agency’s top vaccine regulator said that a review had found that the children were likely to have died “because of” the shots. But public…

ByHeart, the maker of the product, has been linked to an outbreak of illnesses among infants that led to their hospitalizations.

A gene therapy for Duchenne muscular dystrophy caused complications to the liver, prompting a review of its use for younger patients.

The official, Dr. George F. Tidmarsh, a top regulator at the agency, said disagreements over a new program to rapidly approve medications had caused tensions…

The president’s call for removal of the metal from childhood inoculations set off alarms. About half of shots for polio, whooping cough and other diseases…

Aaron Siri is leading legal efforts on policies that dovetail with parts of Health Secretary Robert F. Kennedy Jr.’s government agenda.

The agency revived an old treatment for cancer patients, unilaterally approving it for a subset of people with autism. Experts worry that the narrower scope…

The agency’s staff scientists pointed out how Covid was still unpredictable and posed a threat to toddlers, but the official decided to restrict shots only…