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

By Mariam Sunny and Michael Erman Feb 11 (Reuters) - A U.S. Food and Drug Administration official on Wednesday defended the ...

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

Moderna noted the FDA did not identify any specific safety concerns with the vaccine and that the rejection was inconsistent with previous feedback.

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

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

In a news release late Tuesday, Moderna said it was blindsided by the FDA’s refusal, which the FDA cited as being due to the design of the company’s Phase 3 trial for its mRNA flu vaccine, dubbed mRNA ...

The Food and Drug Administration has refused to review an application from the biotech company Moderna to approve its mRNA-based flu vaccine. The agency’s decision, which Moderna announced in a press ...

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.