FDA, mRNA and Moderna
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The Food and Drug Administration (FDA) is getting ready to evaluate Moderna’s messenger RNA-based flu shot, MFLUSIVA, Fierce Biotech reported, and the landscape appears more positive than investors might have expected. The problem is larger than a single seasonal vaccine.
In recent days, Moderna and Merck reported five-year Phase 2b data showing that their personalized mRNA melanoma vaccine intismeran autogene, combined with Keytruda, substantially reduced the risk of cancer recurrence,
Moderna stays in focus as its mRNA pipeline keeps drawing attention across biotechnology and the broader healthcare space.
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What are mRNA vaccines, and how do they work?
Many people first learned about mRNA vaccines during the coronavirus pandemic, when the companies Pfizer-BioNTech and Moderna released their COVID-19 vaccines. The Pfizer-BioNTech shot was the first COVID-19 vaccine to earn emergency authorization in the ...
FDA Prescription Drug User Fee Act (PDUFA) goal date remains August 5, 2026 CAMBRIDGE, MA / ACCESS Newswire / June 18, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological
Moderna’s mRNA-centric business is in conflict with the U.S. government’s shifting views on mRNA technology, and analysts say that’s a risk. The biotech announced Tuesday evening that in a rare move, the Food and Drug Administration won’t review ...
