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.

Vinay Prasad, the Trump administration’s top vaccine regulator at the Food and Drug Administration, single-handedly decided ...

The head of the agency’s vaccine division, Vinay Prasad, has overruled pushback from career staffers.

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.

In this week’s edition of InnovationRx, we look at the healthcare giants on Forbes new Greatest Innovators list, why Garner ...

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 ...

Under Health Secretary Robert F. Kennedy Jr., the Food and Drug Administration has taken an aggressive stance against mRNA ...

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 ...

Moderna, Inc. vs. Novavax, Inc.: cost cuts, vaccine pipeline catalysts, and valuations. Click for this comparison of NVAX and MRNA and see which is better for you.

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 ...