After the FDA’s decision to reject a review of Moderna’s mRNA-1010 flu shot, executives explain what Americans will miss out on as other nations embrace the technology.

Leveraging its integrated "design-synthesis-quality control" system, Creative Biolabs is overcoming bottlenecks in mRNA ...

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

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

Drug observers puzzled by vaccine maker, which made a killing on COVID-19, failing to read the room with new administration. Moderna puts heat on FDA vaccines chief who's already been rebuked once by ...

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

Therapeutic mRNA delivered via lipid nanoparticles restored sperm production in genetically infertile mice and produced live ...

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

"The FDA rejected Moderna's application for filing because the company refused to follow very clear FDA guidance from 2024 to ...

The US pharma firm’s 40,000-person study suggested its new shot was more effective than a standard flu vaccine.

Moderna claimed that the decision, issued by top vaccine regulator Vinay Prasad, was “inconsistent” with prior FDA ...

FDA refuses Moderna's mRNA flu vaccine application, citing inadequate study design, as the company disputes decision, saying it contradicts prior FDA guidance.