Clinical Trials Arena

FDA reversal on mRNA-1010 could transform the seasonal influenza vaccines market

Moderna has announced that the FDA will initiate the review of its seasonal influenza vaccine candidate, mRNA-1010.

Moderna Receives Refusal-to-File Letter from the U.S. Food and Drug Administration for Its Investigational Seasonal Influenza Vaccine, mRNA-1010

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna ...

The FDA Refuses To Review Moderna’s Flu Vaccine

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

FDA launches multipronged attack on flu vaccines

On Feb. 10, pharmaceutical company Moderna announced that the FDA Center for Biologics Evaluation and Research (CBER) had refused to review its application to market an investigational mRNA-based flu ...

Moderna stock rises. FDA will review its seasonal flu vaccine after all.

The U.S. Food and Drug Administration will review the investigational seasonal flu vaccine candidate after rejecting it ...
GlobalData on MSN

FDA declines to review Moderna’s seasonal flu mRNA vaccine

The FDA’s call comes within a wider push from the US government to alter vaccine policy.
Nature

Unleashing the power of artificial intelligence and machine learning for seasonal influenza

GSK’s long-standing commitment to influenza prevention and innovation has driven advances in vaccine development. Today, GSK continues to harness its capabilities through innovative approaches to the ...
Opinion

FDA’s refusal to review Moderna flu vaccine generates immediate political backlash

While the Trump administration focuses on a deworming medication as a possible cancer cure, it's taking a different approach to a potential flu vaccine.

FDA refuses to review Moderna's influenza vaccine application

By Sneha S K Feb 10 (Reuters) - The U.S. Food and Drug Administration will not review Moderna's approval application for its influenza vaccine, the company said on Tuesday, sending its shares down 8% ...