Moderna said its new flu shot has been cleared for review in Australia, Canada and the European Union. It has asked to meet ...

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 ...

The post Clinical Trials Show Moderna's New mRNA Flu Vaccine Is Safe and Effective. FDA Won't Even Consider It. appeared ...

Moderna’s mRNA influenza vaccine faces US regulatory delays after a refusal-to-file letter from top FDA official Dr Vinay Prasad.

The sudden departure stands in contrast to other EU pharma leaders who have been given much longer transitions in recent months, including GSK’s Emma Walmsley and Novo Nordisk’s Lars Fruergaard ...

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

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

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

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

A universal vaccine would work to help combat the development of AMR in several ways. Firstly, it would protect the individual from getting infected. Prevention of primary infection removes the ...

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

The U. Food and Drug Administration will not review Moderna's approval application for its influenza vaccine, the company ...