The new guidance is intended to “foster drug product development, ANDA submission and approval, and ultimately provide increased access to generic drugs."
2023 brought record-breaking heat waves in the United States, significantly impacting vulnerable groups. Analysis by the CDC revealed a substantial number of heat-related illness (HRI) emergency department visits, resulting in multiple public health alerts.
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Three of the fatalities showed a common pattern of symptoms and the deaths happened close to the time of dosing, while a non-fatal adverse event showed a similar proximity to dosing.
Explore the FDA's proposed changes for biosimilar drugs and their interchangeability, including expert insights on regulatory impacts and market dynamics.
The FDA has approved guselkumab (TREMFYA®) for moderately to severely active Crohn’s disease, supported by Phase 3 trial data showing clinical and endoscopic superiority over ustekinumab.
NIH director, Dr. Monica M. Bertagnolli, is stepping down after launching major initiatives in women's health and long COVID research, indicating optimism for their continuation under new leadership.