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 ...

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 ...

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 has ...

GSK RSV Vaccine Wins EU Adult Approval As Shares Trade Above Targets

GSK's RSV vaccine Arexvy has received European Commission approval for use in adults aged 18 and over. The decision expands ...

Moderna shares fall premarket as FDA declines to review new flu shot vaccine

By Rashika Singh Feb 11 (Reuters) - Shares of Moderna fell 10.3% premarket on Wednesday after the U.S. Food and Drug ...
Devdiscourse

Moderna's Vaccine Ambitions Hit by FDA Roadblock

Moderna faces a setback as shares drop 9% due to the FDA's refusal to review its influenza vaccine application. This decision ...
Becker's Hospital Review

FDA refuses to review Moderna flu vaccine

FDA refuses review Moderna flu vaccine due to comparator arm concerns, despite no safety or efficacy issues, prompting a Type ...
PharmExec

FDA Sends Refusal-to-File Letter to Moderna for Seasonal Influenza Vaccine, Enters Long-Term Agreement with Government of Mexico

A regulatory setback for Moderna’s next-generation flu vaccine underscores mounting scrutiny of late-stage trial design in the U.S., even as the company pivots to international manufacturing ...
Michael Heaver on MSN

The end of Europe as we know it | EU's Draghi calls for federal United States of Europe superstate

The end of Europe as we know it | EU's Draghi calls for federal "United States of Europe" superstate.
BioSpace

Flu Vaccine Rejection Imperils Moderna’s Breakeven Plans

Moderna’s mRNA-1010 was expected to contribute $1 billion to the company’s coffers by 2028. That plan is now out the window after the FDA refused to even look at the application.

Moderna, Inc.: 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 has requested a Type A meeting to understand the path forwardmRNA-1010 has been ...