The U.S. Food and Drug Administration is refusing to consider Moderna's application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday.The news is the l
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The new shot was not compared to “the best-available standard of care in the United States at the time of the study,” an FDA official told Moderna.
Moderna Inc (NASDAQ:MRNA, XETRA:0QF) shares fell almost 6% after the drugmaker announced that the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has issue

Why Moderna Stock Is Sinking Today

12:29pm, Wednesday, 11'th Feb 2026
Moderna (MRNA) shares slid about 10% in U.S. premarket trading Wednesday after the U.S. Food and Drug Administration declined to review its application for seas
Moderna shares sink 10% after FDA issues Refusal-to-File letter for its mRNA-1010 flu vaccine, citing trial design concerns despite no safety flags.
Philadelphia, Pennsylvania--(Newsfile Corp. - February 11, 2026) - Kehoe Law Firm, P.C. is investigating potential securities fraud claims on behalf
The biotech company said the FDA won't review its flu vaccine, in the latest hit to mRNA development.

Stock Futures Jump on Strong January Jobs Report

09:20am, Wednesday, 11'th Feb 2026
Stock futures are higher this morning after strong jobs data
Moderna Inc (NASDAQ:MRNA, XETRA:0QF) shares fell almost 6% after the drugmaker announced that the US Food and Drug Administration’s (FDA) Center for...
Stock News FDA refuses to file Moderna's flu shot: Moderna (MRNA) said the FDA issued a refusal-to-file letter for its mRNA flu vaccine application, citing tria

Breakfast News: First SaaS, Now Finance Hit By AI

07:30am, Wednesday, 11'th Feb 2026
AI makes move into tax planning, Shopify and Unity report this morning, and more
The vaccine maker says the Food and Drug Administration has refused to review its application to sell a new seasonal flu vaccine.
Amazon (AMZN) acquires a 5.3% stake in BETA Technologies, sharply boosting BETA's premarket share price. Moderna (MRNA) faces an FDA refusal-to-file for its mRNA-1010 influenza vaccine, citing inadequ
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