Moderna says the FDA will consider its new flu shot after resolving a public dispute - Associated Press News

Moderna says the FDA will consider its new flu shot after resolving a public dispute  Associated Press News

US FDA reverses course, will review Moderna's modified flu vaccine application - Reuters

US FDA reverses course, will review Moderna's modified flu vaccine application  Reuters

F.D.A. Reverses Decision and Agrees to Review Moderna’s Flu Vaccine

Moderna said it had held further discussions with regulators and announced that the agency would accept the company’s application for approval of its flu vaccine that uses mRNA technology.

By Christina Jewett and Rebecca Robbins

FDA Reverses Course and Will Now Review Moderna’s Flu Shot - The Wall Street Journal

FDA Reverses Course and Will Now Review Moderna’s Flu Shot  The Wall Street Journal

Trump administration reverses move to block Moderna flu vaccine trial

U-turn comes after backlash from the company and US biotech industry

The FDA’s damage to medical innovation will be hard to repair

The regulator’s about-face is welcome, but problems remain.

By Editorial Board

FDA reverses course and will review Moderna’s mRNA-based flu vaccine

US drug regulator originally refused to consider application, fueling critics’ concern about alleged ‘anti-vaccine agenda’ The Food and Drug Administration (FDA) reversed course on Wednesday and will now review Moderna’s application for the first mRNA-based flu vaccine after initially declining to consider it. Moderna announced that the US drug regulator will move forward with reviewing its updated flu vaccine application. The decision comes only a week after the agency turned down the company’s original filing, a move that had prompted criticism across the medical industry about potential changes in how the regulator is making decisions under the Trump administration. Continue reading...

By Marina Dunbar

FDA reverses course on Moderna flu shot

A little more than a week after the FDA rattled the biotech industry by rejecting Moderna's mRNA flu vaccine without even reviewing the application, the agency changed course. But there's a catch.

By Sydney Lupkin

US says that it will review Moderna flu vaccine it previously declined

The pharmaceutical giant expressed optimism that its new flu shot would be available this year, after approval concerns.

FDA agrees to review Moderna’s mRNA flu vaccine application in a reversal

The FDA is slated to make a decision on the flu shot on Aug. 5, which will allow Moderna to make the vaccine available for the upcoming influenza season.

Moderna got the FDA to change its mind and review its flu vaccine after some concessions

Moderna’s stock was surging after the FDA said it would review the biotech’s flu-vaccine candidate, a week after it had refused to do so.

By Tomi Kilgore

Moderna gains as FDA backtracks and accepts flu shot for review