At issue with Moderna's mRNA flu shot is communication from CBER to Moderna suggesting that the company’s vaccine be compared against a control shot designed more specifically for older people.

The F.D.A.’s refusal to examine the company’s mRNA shot drew widespread criticism from doctors and was divisive within the agency.

Regulators move the goalposts for a manufacturer that uses mRNA technology.

The Food and Drug Administration is refusing to consider Moderna's application for a new flu vaccine made with mRNA technology, the company said.

The FDA refused to review Moderna’s application for a new flu vaccine, the company said yesterday. It’s a surprising decision that could raise concerns about the agency’s posture toward drug companies ...

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 ...

The vaccine maker’s shots involve the successful Covid vaccines’ RNA technology. Health Secretary Robert F. Kennedy Jr. has ...

Five years ago, Moderna, Inc. (MRNA) and Novavax, Inc. (NVAX) were two of the most talked about stocks across platforms like Seeking Alpha, social media, and likely in the national press of most ...

Moderna will continue to lead clinical development and manufacturing of the asset, while Recordati will handle commercialization of mRNA-3927, which is under development for the rare metabolic ...

As the Trump administration erodes U.S. infrastructure supporting infectious disease vaccines, mRNA heavyweight Moderna plans to pull away from late-stage clinical trial investments in the area. “We ...