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Moderna Inc (NASDAQ:MRNA) has delivered a 37% gain year-to-date, dramatically outpacing the biotech sector's 0.4% YTD return.
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 latest sign of the FDA's heightened scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr., particularly those using mRNA technology, which he has criticized before and after becoming the nation's top health official.Moderna received what's called a “refusal-to-file” letter from the FDA that objected to how it conducted a 40,000-person clinical trial comparing its new vaccine to one of the standard flu shots used today.
The head of the agency's vaccine division, Vinay Prasad, has overruled pushback from career staffers.
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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 issued a Refusal-to-File (RTF) letter for the company's biologics license application for its investigational seasonal influenza vaccine, mRNA-1010. According to the company, the FDA cited the choice of a licensed standard-dose influenza vaccine as the comparator in Moderna's Phase 3 trial as the reason for the refusal.
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.
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The biotech company said the FDA won't review its flu vaccine, in the latest hit to mRNA development.
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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
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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 inadequate trial controls but no safety or efficacy issues.
Moderna shares opened 14% lower in Frankfurt on Wednesday in low volume after the U.S. Food and Drug Administration refused to review the company's approval application for its influenza vaccine.
The company said the agency wouldn't review its application on the grounds that the study testing the shot wasn't sufficient.
Moderna said on Tuesday the U.S. Food and Drug Administration will not review its approval application for its influenza vaccine.
The Food and Drug Administration 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 tightening vaccine regulation in the U.S.