Ron Lanton Discusses FDA’s Single-Trial Approval Pathway with Pharmaceutical Executive

Ron Lanton spoke with Pharmaceutical Executive about the FDA’s evolving approach to drug approvals and the potential shift toward a single-trial evidentiary pathway. The discussion examines how changes in regulatory expectations could affect development strategy, litigation exposure, and pricing dynamics across the pharmaceutical sector. As regulatory signals increasingly influence market strategy, companies developing innovative therapies must evaluate not only the scientific strength of their programs but also how evolving FDA policy may shape investor expectations and commercialization timelines. Listen to the interview here.

Ron Lanton Discusses Moderna mRNA Regulatory Uncertainty with Pharmaceutical Executive

Ron Lanton spoke with Pharmaceutical Executive about regulatory uncertainty surrounding Moderna’s mRNA influenza vaccine review and what it could signal for the broader biotechnology sector. The discussion focused on how shifts in regulatory signals can influence market confidence in platform technologies such as mRNA and whether those signals could affect the development strategies of other manufacturers. Listen to the discussion here.