The Food and Drug Administration has refused to review Moderna’s application for an mRNA flu vaccine, the company revealed Tuesday. While the move came as a surprise to the high-profile vaccine maker, ...
Moderna said the move is inconsistent with previous feedback from the FDA on the experimental influenza shot, called ...
Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has ...
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FDA refuses to review Moderna's flu vaccine application
The FDA declined to review Moderna’s experimental flu vaccine over trial design concerns, despite no safety issues. The ...
Moderna Inc. (NASDAQ: MRNA) shares declined sharply in after-hours trading on Tuesday after the biotechnology company ...
The U.S. Food and Drug Administration (FDA) has declined to review Modernas approval application for its experimental influenza vaccine, mRNA-1010, a decision that sent the companys shares down about ...
The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu ...
Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has requested a Type A meeting to understand the path forwardmRNA-1010 has been ...
During the first year of the Trump administration, signs of an anti-mRNA slant within the FDA and HHS became more and more ...
Hyperkalemia was more common among older women treated with spironolactone for a skin condition, and among those with comorbidities, but cases were usually mild and rarely altered care, a study ...
A living evidence approach treats evidence as shared infrastructure rather than as a series of isolated projects.
Raja Shankar, VP of machine learning at IQVIA, discusses which AI capabilities sponsors are most likely to adopt first to ...
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