In a news release late Tuesday, Moderna said it was blindsided by the FDA’s refusal, which the FDA cited as being due to the design of the company’s Phase 3 trial for its mRNA flu vaccine, dubbed mRNA ...

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has ...

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 vaccine, the company said Tuesday, in another setback for the technology ...

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 ...

Moderna said the move is inconsistent with previous feedback from the FDA on the experimental influenza shot, called ...

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 ...

During the first year of the Trump administration, signs of an anti-mRNA slant within the FDA and HHS became more and more ...

Raja Shankar, VP of machine learning at IQVIA, discusses which AI capabilities sponsors are most likely to adopt first to ...

On January 16, 2026, the U.S. Supreme Court granted certiorari in Anderson v. Intel Corp. Investment Policy Committee, No. 25 ...