CMC hurdles stall Korea drug approvals as KDDF and KCMC mobilize support National push aims to build end‑to‑end CMC capacity as costs rise and FDA scrutiny intensifies ...

Developing a new medication can cost over $1 billion, depending on the drug’s complexity and expenses accrued via unsuccessful studies. Considering these costs, an optimized regulatory process is ...

Industry experts shared their insights and expertise on overcoming the most pressing Chemistry, Manufacturing, and Controls (CMC) challenges at LSX Biopharm America on September 11. This article ...

As pipelines across modalities diversify, regulatory scrutiny intensifies, and the margin for error in development execution continues to shrink, partnering with a CDMO has never been more critical.