Moderna, Inc.

The US Food and Drug Administration’s June user fee goal calendar reflects the gravitational pull of major meetings. The month opens with the monster American Society of Clinical Oncology annual meeti

Confused and alarmed stakeholders worry that Health and Human Services Secretary Robert F. Kennedy Jr. usurped a role long played by the US Centers for Disease Control and Prevention and its external

Contract manufacturing of biologics is one of the few weak points in the typically overwhelming advantage the US holds over Europe in bestowing the first approval for new drug products, a Pink Sheet

The US Food and Drug Administration’s vaccine advisors split on whether COVID-19 vaccine manufacturers should update shots with a new strain for the 2025-2026 vaccine season, as uncertainty about the