The decision, which shocked company officials, comes as the FDA says it will take a stricter approach to federal vaccine ...
The Food and Drug Administration rejected Moderna’s application for its mRNA-based flu vaccine, the drugmaker said Tuesday ...
"The FDA rejected Moderna's application for filing because the company refused to follow very clear FDA guidance from 2024 to ...
Drug observers puzzled by vaccine maker, which made a killing on COVID-19, failing to read the room with new administration. Moderna puts heat on FDA vaccines chief who's already been rebuked once by ...
In a small clinical trial, customized mRNA vaccines against high-risk skin cancers appeared to reduce the risk of cancer recurrence and death by nearly 50 percent over five years when compared with ...
Leveraging its integrated "design-synthesis-quality control" system, Creative Biolabs is overcoming bottlenecks in mRNA ...
Moderna (MRNA) stock fell 9% premarket after FDA rejected its flu vaccine application due to trial design issues, despite ...
The FDA declined to review Moderna's mRNA influenza vaccine due to inadequate clinical trial comparators for older adults.
Moderna claimed that the decision, issued by top vaccine regulator Vinay Prasad, was “inconsistent” with prior FDA ...
The US pharma firm’s 40,000-person study suggested its new shot was more effective than a standard flu vaccine.
FDA refuses Moderna's mRNA flu vaccine application, citing inadequate study design, as the company disputes decision, saying it contradicts prior FDA guidance.
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