Moderna, Inc. (MRNA)
The FDA's refusal to review Moderna's application to sell a new flu shot is part of a pattern of regulatory U-turns and overruling of FDA staff by Vinay Prasad, head of the agency's vaccine division
The head of the agency's vaccine division, Vinay Prasad, has overruled pushback from career staffers.
FDA blindsides Moderna with refusal to review flu vaccine application: ‘We're pretty confused'
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's investigational flu vaccine denied FDA review, shares drop
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.
MRNA Down Nearly 10% as FDA Refuses to Review Influenza Vaccine BLA
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.
Moderna's work developing seasonal vaccines is ‘risky' under current FDA, analyst says
The biotech company said the FDA won't review its flu vaccine, in the latest hit to mRNA development.
Wall Street Breakfast Podcast: Amazon Adds BETA To Cart
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 fall after FDA refuses to review new flu vaccine
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.
Moderna says FDA refuses to review its application for experimental flu shot
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.
The FDA has refused to review Moderna's application to sell a new flu shot, the latest move by the administration against vaccines
The company said the agency wouldn't review its application on the grounds that the study testing the shot wasn't sufficient.
Moderna (MRNA) Laps the Stock Market: Here's Why
In the latest trading session, Moderna (MRNA) closed at $41.95, marking a +2.29% move from the previous day.
Moderna to Report Q4 Earnings: Is a Beat in Store for the Stock?
MRNA is set to report Q4 results on Feb. 13, with expectations for an earnings beat as COVID vaccine sales and pipeline updates stay in focus.
Moderna (MRNA) Expected to Beat Earnings Estimates: What to Know Ahead of Q4 Release
Moderna (MRNA) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
