The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel ...

Moderna said the move is inconsistent with previous feedback from the FDA on the experimental influenza shot, called ...

The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu ...

Moderna said on Tuesday the U.S. Food and Drug Administration will not review its approval application for its influenza ...

Federal health officials said Tuesday they will reassess the safety of a chemical called BHA used in foods including potato ...

The Food and Drug Administration is undertaking a review of the chemical preservative butylated hydroxyanisole to determine ...

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has ...

The U.S. Food and Drug Administration on Tuesday launched a broad review of a long-used synthetic preservative used in ...

The Marshall Project found more than 70,000 cases referred to law enforcement over allegations of substance use during ...

The Food and Drug Administration rejected Moderna’s application for its mRNA-based flu vaccine, the drugmaker said Tuesday ...

The decision, which shocked company officials, comes as the FDA says it will take a stricter approach to federal vaccine approvals.

FDA's new medical device quality management rules align U.S. standards with global requirements and give inspectors new ...