CEO Stéphane Bancel emphasized the need for a comprehensive review using an FDA-approved comparator and expressed a goal of transparency to gain clarity on the path forward.

The report places Moderna’s filing amid a broader U.S. policy shift in health leadership, with vaccine policy and federal research priorities potentially influenced by political figures in the current administration’s orbit.

The FDA has issued a refusal-to-file letter to Moderna, signaling that the agency will not consider Moderna’s new mRNA-based flu vaccine application in its current form due to concerns that the trial did not use the best-available standard of care for comparison.

Experts warn that a restrictive regulatory direction could have broader implications for the mRNA platform and future vaccine development.

Mid-sized biotech firms show solidarity in response to proposed drug pricing policy, signaling industry-wide concern about policy shifts.

Regulatory actions related to compounding include FDA warnings, a Justice Department investigation request, and a Novo Nordisk patent dispute against Hims & Hers, signaling a tightening environment for compounded products.

Some note the unusual nature of the letter being signed by the center’s director and raise questions about alignment between staff recommendations and the final decision.

(With inputs from agencies.)

Other items in the issue include broader healthcare policy moves, AI in healthcare discussions, and industry moves like Lilly’s acquisition of Orna Therapeutics.

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Analysts are watching whether the administration’s stance on vaccines and compounding will heighten regulatory pressure on companies and telehealth platforms, affecting patient access and industry practices.