Moderna Receives Refusal-to-File Letter from the U.S. Food and Drug Administration for Its Investigational Seasonal Influenza Vaccine, mRNA-1010

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

Moderna hit with FDA refusal-to-file letter for mRNA flu shot, issues sharp rebuke of agency's rationale

During the first year of the Trump administration, signs of an anti-mRNA slant within the FDA and the Department of Health and Human Services (HHS) became more and more evident. | The FDA specifically took issue with the trial's control arm,

Moderna Announces Strategic Collaboration with Recordati to Globally Commercialize Investigational Propionic Acidemia Therapeutic (mRNA-3927)

Moderna will continue to lead clinical development and manufacturing for mRNA-3927Moderna to receive up to $160 million

Moderna’s work developing seasonal vaccines is ‘risky’ under current FDA, analyst says

The biotech announced Tuesday evening that in a rare move, the Food and Drug Administration won’t review its application for a mRNA-based flu vaccine over concerns about the choice of vaccine tested against the experimental vaccine in Phase 3 clinical trials. Moderna described the FDA as “inconsistent” in its communications.
Kalkine Media

Moderna (NASDAQ:MRNA) Aligned With Nasdaq Index Biotech Presence

Moderna advances messenger RNA platform technologies Therapeutics pipeline spans vaccines and disease targets nasdaq index inclusion reflects biotech scale Moderna, Inc. (NASDAQ:MRNA) operates within the biotechnology sector and remains a recognized component of the broader nasdaq index,

Moderna Patent Ruling And New Development Chief Reframe mRNA Growth Story

Moderna (NasdaqGS:MRNA) is involved in an ongoing patent infringement case related to its COVID-19 vaccine, with a recent court ruling addressing claims from Arbutus Biopharma and Genevant. The company has appointed Dr.