Moderna confirmed this morning that the FDA has had a change of heart on the marketing application for its influenza vaccine mRNA-1010, and will now start a review. There was shock last week when the ...

CNET editor Gael Fashingbauer Cooper, a journalist and pop-culture junkie, is co-author of "Whatever Happened to Pudding Pops? The Lost Toys, Tastes and Trends of the '70s and '80s," as well as "The ...

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The FDA has accepted Moderna’s revised influenza vaccine filing days after controversially refusing to review the original submission, putting the biotech on track to win approval in time for the 2026 ...

CBER moved the BLA into filing review days after an RTF, centered on disagreement that a standard-dose licensed comparator represented contemporary best-available influenza vaccination. Regulatory ...

After the FDA’s decision to reject a review of Moderna’s mRNA-1010 flu shot, executives explain what Americans will miss out on as other nations embrace the technology. The rest of the world may get ...

The Food and Drug Administration has refused to review Moderna’s application for an mRNA flu vaccine, the company revealed Tuesday. While the move came as a surprise to the high-profile vaccine maker, ...

The Food and Drug Administration has refused to start a review of Moderna's application for its experimental flu shot, the company said. It's another sign of the Trump administration's influence on ...

The Element New Orleans Downtown by Marriott will officially open Thursday, Feb. 5. The 216-room extended-stay hotel, located at 221 O’Keefe Ave., represents the first phase of a mixed-use ...

U.S. IND represents the second regulatory clearance for KLN-1010 and enables the first multi-center clinical trial in the U.S. for an anti-BCMA in vivo CAR-T program BOSTON, January 07, ...