The mRNA Therapeutics Regulatory Paradigm: A Closer Look

In some ways, it has been a quiet(er) year on the regulatory front for mRNA; there have been no mRNA-specific guidances released since the MHRA personalized cancer immunotherapy guidance and the EMA’s mRNA vaccine quality guidance — both of which were released in the winter of 2025. However, there has been a flurry of activity at the FDA, including new leadership appointments and the release of several guidances impacting the advanced therapies/personalized medicines sector. In this discussion, Advancing RNA Live Chief Editor Anna Rose Welch, Eliquent Life Sciences' Tiffany Lucas, and NDA Partners' Daniela Drago dig into current events and recent guidance to identify the impacts these developments will have on the mRNA sector overall.