The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.

The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use ...

A recall of millions of eggs due to potential salmonella contamination has now been issued the highest risk warning by the ...

Federal documents show he disagreed with conclusions the benefits outweighed the risk of side effects, which are rare.

The approval of sunvozertinib, an oral irreversible EGFR inhibitor, was supported by data from the WU-KONG1B trial (ClinicalTrials.gov Identifier: NCT03974022 ). The primary efficacy population ...

FDA escalates organic blueberry recall to highest risk level over deadly listeria contamination. Health officials warn of ...

The FDA has upgraded Alma Pak’s blueberry recall to the highest risk level following positive tests for Listeria ...

Agency will require a Limitation of Use section in the prescribing information of all extended-release ADHD stimulants ...

University of Minnesota spinout Fasikl has obtained an FDA clearance for its artificial-intelligence-powered wearable for ...

Published on June 18, 2024, this rule revises requirements around current good manufacturing practice (CGMP), post-marketing ...

Dr. George Tidmarsh, physician, scientist, and biotech CEO, joins Jerry Rogers on "The Business of America" podcast to ...

Regeneron Pharmaceuticals said on Wednesday the U.S. Food and Drug Administration has approved its drug for a type of blood ...