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

America’s drug safety agency declined to review a next-gen flu vaccine that uses the same tech as the coronavirus shots ...

It’s rare that FDA refuses to file an application, particularly for a new vaccine, which requires companies and FDA staff to ...

The Food and Drug Administration on Wednesday defended its rejection of Moderna’s mRNA-based flu vaccine application, saying the company’s clinical trial design put patients at risk ...

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

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

Moderna (MRNA) stock fell 9% premarket after FDA rejected its flu vaccine application due to trial design issues, despite ...

Some genetic mutations that are expected to completely stop a gene from working surprisingly cause only mild or even no symptoms. Researchers in previous studies have discovered one reason why: cells ...

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.

The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu vaccine, the company said Tuesday, in another setback for the technology ...