Moderna shares sink 10% after FDA issues Refusal-to-File letter for its mRNA-1010 flu vaccine, citing trial design concerns ...
FDA issues a Refusal to File letter to Moderna (NasdaqGS:MRNA) for its influenza vaccine candidate mRNA-1010. The decision ...
The FDA has refused to review Moderna’s application for its messenger RNA-based influenza vaccine, according to the company.In a press release, Moderna noted that the FDA’s rejection of the vaccine, ...
A regulatory setback for Moderna’s next-generation flu vaccine underscores mounting scrutiny of late-stage trial design in the U.S., even as the company pivots to international manufacturing ...
By Rashika Singh and Mariam Sunny Feb 11 (Reuters) - Shares of Moderna slumped over 10% on Wednesday after the U.S. Food and ...
Moderna (MRNA) stock fell 9% premarket after FDA rejected its flu vaccine application due to trial design issues, despite ...
FDA refuses Moderna's mRNA flu vaccine application, citing inadequate study design, as the company disputes decision, saying it contradicts prior FDA guidance.
6hon MSN
FDA blindsides Moderna with refusal to review flu vaccine application: ‘We’re pretty confused’
The Food and Drug Administration refused to review Moderna’s application for its new mRNA flu vaccine — a move the pharma ...
Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna ...
Moderna claimed that the decision, issued by top vaccine regulator Vinay Prasad, was “inconsistent” with prior FDA ...
The new oral therapy demonstrates superior lesion healing for complex patients who have few current treatment options.
The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu ...
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