Discussion to Cover the Importance of Early-Stage CMC Testing in Enhancing Biologic Predictability, Scaling Up, and Accelerating Time to Market KAISERAUGST, Switzerland, April 22, 2025 /PRNewswire/ -- ...

Enhancements enable pharma, biotech and generics companies to streamline regulatory tracking and optimize life cycle management for small molecules and biologics CMC activities account for nearly 18% ...

Biologics manufacturers urged to develop a chemistry, manufacturing, and controls (CMC) management strategy for reference material early.

"Regulatory flexibility must be tailored for cell and gene therapies," said FDA Commissioner Marty Makary, M.D., M.P.H. "These are common-sense reforms that will address the unique characteristics of ...

Recognized as Biologics CDMO of the Year, BioDlink shares insights into the world's first approved EGFR-targeted ADC for recurrent/metastatic nasopharyngeal carcinoma The company enables seamless ...

* Portola Pharmaceuticals- pursuant to agreement, cmc will provide other services supporting co's regulatory applications in United States, European Union * Portola Pharmaceuticals Inc- under ...

Y-Biologics said on the 7th that it signed a contract manufacturing and development (CDMO) deal with China's WuXi Biologics to develop new drugs using its next-generation triple-target immuno-oncology ...

Sherry Gu, Executive Vice President and CTO at WuXi Biologics, explains the critical challenges of developing bispecific ...