Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...

On the FDA’s docket this month are two expansion bids, one for GSK’s asthma drug Nucala into COPD and another for Merck’s ...

There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...

Steven Hatfill promoted hydroxychloroquine during the pandemic. Decades earlier he was wrongly connected with the anthrax ...

“Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to ...

The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 ...

The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve COVID-19 vaccines for next winter, citing a lack of data on booster shots.

Moderna is deprioritizing its flu/COVID combination vaccine in younger adults amid a push to cut about $1.5 billion from its ...

Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.

Have you ever wondered about what became of COVID vaccine companies after the pandemic settled down? Find out in this article ...

The Food and Drug Administration was set to release new guidance on COVID booster shots ahead of the fall season, but that's ...

Novavax says its closely watched COVID-19 vaccine is on track for full U.S. approval after additional discussions with the ...